FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other excipients are citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections.
Maltese: - L-eċċipjenti l-oħra huma citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections.
English: Crossover patients received up to 46 months of mogamulizumab therapy, as of December 2016 data cut.
Maltese: Pazjenti li qalbu ngħataw sa 46 xahar ta' terapija bi mogamulizumab, mid-datacut ta' Diċembru 2016.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, monoclonal antibodies ATC code: L01XC25
Maltese: Aġenti antineoplastiċi u immunomodulanti, antikorpi monoklonali, Kodiċi ATC:
English: See section 4.2 for premedication and dose modification information.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar premedikazzjoni u modifiki tad-doża.
English: The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Maltese: Il-konċentrazzjoni finali tas-soluzzjoni dilwita għandha tkun bejn 0.1 mg/mL u 3.0 mg/mL.
English: CCR4 was detected on ≥1% of lymphocytes in 100% of patients, and 96% (134/140) had CCR4 detected on ≥10% of skin lymphocytes.
Maltese: CCR4 ġiet identifikata fuq ≥1 % tal-linfoċiti f'100 % tal-pazjenti, u 96 % (134/140) kellhom CCR4 li ġiet identifikata fuq ≥10 % tal-linfoċiti tal-ġilda.
English: Anaemia, neutropenia, leukopenia, Thrombocytopenia
Maltese: Anemija, newtropenja, lewkopenja,
English: Severe reactions (Grade 3) were experienced by 4% of patients.
Maltese: Reazzjonijiet severi (Grad 3) kienu esperjenzati minn 4% tal-pazjenti.
English: The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months).
Maltese: It-tul ta' żmien medjan ta' esponiment b'mogamulizumab kien ta' 5.6 xhur (medda: <1 sa 45.3 xhur).
English: POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab
Maltese: POTELIGEO 4 mg/mL konċentrat għal soluzzjoni għal infużjoni mogamulizumab
English: Uncommon Hepatitis acute, hepatitis
Maltese: Mhux komuni Epatite akuta, epatite
English: Of these, SADRs that were reported in more than one patient were coded under the SOCs Infections and infestations (7 [2.2%] patients), General disorders and administration site conditions (5 [1.6%] patients), Respiratory, thoracic and mediastinal disorders (4 [1.3%] patients), Musculoskeletal and connective tissue disorders (3 [0.9%] patients), Hepatobiliary disorders (2 [0.6%] patients), and Injury, poisoning and procedural complications (2 [0.6%] patients).
Maltese: Infezzjonijiet u infestazzjonijiet (7 [2.2%] pazjenti), Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata (5 [1.6%] pazjenti), Disturbi respiratorji, toraċiċi u medjastinali (4 [1.3%] pazjenti), Disturbi muskolu-skeletriċi u tat-tessuti konnettivi (3 [0.9%] pazjenti), Disturbi fil-fwied u filmarrara (2 [0.6%] pazjenti), u Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura (2 [0.6%] pazjenti).
English: The subjects had a medical history including various risk factors.
Maltese: L-individwi kellhom storja medika inkluż diversi fatturi ta' riskju.
English: Tabulated list of adverse reactions The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Maltese: frekwenza, definiti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10);
English: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased
Maltese: Żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda flalkaline phosphatase fid-demm, tnaqqis fl-għadd ta' linfoċiti
English: The Kaplan-Meier curve for PFS is shown Figure 1.
Maltese: Il-kurva Kaplan-Meier għall-PFS qed tintwera fil-Figura 1.
English: Mogamulizumab exhibits linear PK from the dose in a dose range of 0.01 mg/kg to 1 mg/kg.
Maltese: Linearità u akkumulazzjoni Mogamulizumab juri PK lineari mid-doża f'medda ta' dożi ta' bejn 0.01 mg/kg u 1 mg/kg.
English: <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Table 1: Adverse drug reactions occurring in patients receiving POTELIGEO (N=184) System organ class (SOC)
Maltese: POTELIGEO (N=184) Sistema tal-klassifika tal-organi (SOC) Frekwenza Reazzjoni avversa
English: In the clinical trial (0761-010), there were 2 reports of respiratory failure with fatal outcome in patients with severe pneumonia occurring more than 9 months after starting treatment with mogamulizumab.
Maltese: Fil-prova klinika (0761-010), kien hemm żewġ rapporti ta' insuffiċjenza respiratorja b'eżiti fatali f'pazjenti b'pulmonite severa li seħħew aktar minn 9 xhur wara l-bidu tal-kura bi mogamulizumab.
English: The effects of various covariates on the PK s of mogamulizumab were assessed in population PK analyses.
Maltese: L-effetti ta' diversi kovarji fuq il-PK ta' mogamulizumab ġew ivvalutati f'analiżi PK tal-popolazzjoni.
English: Less than 1% of patients treated in Study 0761-010 discontinued treatment due to infusion-related reactions.
Maltese: Inqas minn 1% tal-pazjenti li ngħataw kura fi Studju 0761-010 waqqfu l-kura minħabba reazzjonijiet relatati mal-infużjoni.
English: Very common Fatigue, oedema peripheral, pyrexia
Maltese: Komuni ħafna Għeja, edema periferali, deni
English: Response rate (confirmed CR + PR, %) 95% CI
Maltese: Rata ta' rispons (CR + PR ikkonfermati, %) 95% CI
English: The effect of renal impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild (creatinine clearance [CrCL] between 60 and 89; n= 157), moderate (CrCL between 59 and 30; n= 80), or severe renal impairment (CrCL less than 30 mL/min; n= 2).
Maltese: L-effett ta' indeboliment tal-kliewi fuq it-tneħħija ta' mogamulizumab ġie vvalutat minn analiżi PK tal-popolazzjoni f'pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina [CrCL] ta' bejn 60 u 89; n= 157), moderat (CrCL ta' bejn 59 u30; n= 80), jew sever (CrCL ta' inqas minn 30 mL/min; n= 2).
English: Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells.
Maltese: IgG1 kappa umanizzata u defucosylated li tintrabat b'mod selettiv ma' CCR4, riċettur akkoppjat mal-proteina G għall-kimokini CC li huwa involut fit trasferiment ta' linfoċiti lejn diversi organi inkluż lill-ġilda, li jwassal għat-tnaqqis taċ-ċelluli fil-mira.
English: Very common Constipation, diarrhoea, nausea, stomatitis
Maltese: Komuni ħafna Stitikezza, dijarea, dardir, stomatite Komuni
English: At 6, 12, 18 and 24 months after the start of randomised treatment, the percent of subjects alive without disease progression was higher for mogamulizumab (55.3%, 38.3%, 28.0%, and 14.1%, respectively) compared to vorinostat (28.8%, 15.3%, 7.2%, and 7.2%, respectively).
Maltese: Fis-6, fit-12, fit-18 u fl-24 xahar wara l-bidu ta' kura randomizzata, il-perċentwal ta' individwi ħajjin mingħajr progressjoni tal-marda kien ogħla għal mogamulizumab (55.3%, 38.3%, 28.0%, u 14.1%,
English: The pharmacokinetics (PK) of mogamulizumab was evaluated in adult patients with T-cell leukaemialymphoma (ATL) and CTCL over a dose range of 0.01 to 1 mg/kg administered as multiple doses of mogamulizumab every week or every 2 weeks, and included the recommended 1.0 mg/kg dose and regimen (days 1, 8, 15 and 22 for the first 28-day cycle and on Days 1 and 15 for subsequent 28-day cycles).
Maltese: Il-farmakokinetika (PK) ta' mogamulizumab ġiet ivvalutata f'pazjenti adulti b'lewkimja-limfoma taċċelluli-T (ATL) u CTCL fuq medda ta' dożi ta' 0.01 għal 1 mg/kg mogħti bħala dożi multipli ta' mogamulizumab kull ġimgħa jew kull ġimagħtejn, u kienet tinkludi d-doża rakkomandata ta' 1.0 mg/kg u r-reġimen rakkomandat (jiem 1, 8, 15 u 22 għall-ewwel ċiklu ta' 28-jum u fil-Jiem 1 u 15 għaċ-ċikli sussegwenti ta' 28-jum).
English: Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO.
Maltese: Reazzjonijiet relatati mal-infużjoni kienu osservati fi 33% tal-pazjenti li ngħataw kura bi POTELIGEO.
English: 5 mL solution in a 10 mL glass vial (type I glass) with a rubber stopper, an aluminium seal and a polypropylene flip-off cap.
Maltese: Soluzzjoni ta' 5 mL f'kunjett tal-ħġieġ ta' 10 mL (ħġieġ tat-tip I) b'tapp tal-gomma, siġill tal-aluminju u għatu tal-polipropilen tat-tip flip-off.
English: 56% of patients received mogamulizumab for at least 6 cycles, and 25% of patients received mogamulizumab for at least 12 cycles.
Maltese: 56% tal-pazjenti rċevew mogamulizumab għal mill-inqas 6 ċikli, u 25% tal-pazjenti rċevew mogamulizumab għal mill-inqas 12-il ċiklu.
English: Table 4: Progression Free Survival (PFS) by Treatment Group and Disease Stage (Randomised Treatment Period)
Maltese: Tabella 4: Sopravivenza Mingħajr Progressjoni (PFS) skont il-Grupp ta' Kura u l-Istadju talMarda (Perjodu ta' Kura Randomizzata)
English: Very common Drug eruption (including skin rash) a Folliculitis, Cellulitis, Candidiasis, Pneumonia, Sepsis, Skin infection, Otitis externa, Herpes zoster, Staphylococcal skin infection, Urinary tract infection, Herpes simplex and cytomegalovirus
Maltese: a Follikulite, Ċellulite, Kandidjasi, Pulmonite, Sepsis, Infezzjoni tal-ġilda, Otite esterna, Herpes zoster, Infezzjoni stafilokokka tal-ġilda, Infezzjoni fl-apparat urinarju, Herpes simplex u ċitomegalovirus
English: Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Maltese: korrezzjoni ta' anormalitajiet fl-elettroliti, terapija antiiperurikemika, u kura ta' sostenn.
English: Based on a population PK analysis, the geometric mean [% coefficient of variation (CV%)] central volume of distribution (Vc) was 3.57 L (20.1%).
Maltese: [% koeffiċjent ta' varjazzjoni (CV%)] kien ta' 3.57 L (20.
English: - Inflammation of the liver (hepatitis)
Maltese: - Infjammazzjoni tal-fwied (epatite)
English: Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients).
Maltese: Ir-raġunijiet għall-qalba għal mogamulizumab kienu progressjoni tal-marda (109 pazjenti) u intolleranza għall-kura (27 pazjent).
English: • Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter.
Maltese: • Għati s-soluzzjoni għall-infużjoni fuq perjodu ta' mill-inqas siegħa permezz ta' linja intravenuża li jkun fiha filtru sterili fil-linja, b'irbit baxx mal-proteini ta' 0.22 mikroni (jew ekwivalenti).
English: P-valuea
Maltese: Valur-Pa
English: In Study 0761-010 there were 10/290 evaluable patients with CCR4 expression <10%, of which 6 were randomised to mogamulizumab, and 4 were randomised to vorinostat and subsequently crossed over to mogamulizumab.
Maltese: Studju 0761-010 kien hemm 10/290 pazjent li setgħu jiġu vvalutati b'espressjoni ta' CCR4 ta' <10%, li minnhom 6 kienu randomizzati għal mogamulizumab, u 4 kienu randomizzati għal vorinostat u sussegwentement qalbu għal mogamulizumab.
English: Disease stage IB/II
Maltese: Marda fi stadju IB/II
English: Of the patients randomised to vorinostat, 136 patients (73.1%) crossed over to mogamulizumab during the study.
Maltese: Mill-pazjenti randomizzati għal vorinostat, 136 pazjent (73.1%) qalbu għal mogamulizumab matul listudju.
English: Duration of response (months) Median (95% CI) Response by compartment Blood n=124
Maltese: Medjan (95% CI) Rispons skont il-kompartiment Demm n=124
English: All patients had a histologically confirmed diagnosis of mycosis fungoides (MF), 56.5%, 53.2%, or Sézary Syndrome (SS), 43.5%, 46.8%, in the mogamulizumab and vorinostat groups, respectively, and had received at least one prior systemic therapy.
Maltese: 53.2%, jew tas-Sindrome ta' Sézary (SS), 43.5%, 46.8%, fil-gruppi ta' mogamulizumab u ta'
English: - have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), or hepatitis B or
Maltese: - għandek il-virus tal-immunodefiċjenza umana (HIV), herpes, ċitomegalovirus (CMV), jew infezzjoni tal-epatite B jew Ċ, jew jekk għandek infezzjonijiet oħra rikorrenti.
English: The efficacy of mogamulizumab in the treatment of patients with mycosis fungoides (MF) or Sézary syndrome (SS) was established in a Phase 3, multicentre, open-label, study (0761-010) of 372 adult patients randomised 1:1 to treatment with either mogamulizumab or vorinostat.
Maltese: L-effikaċja ta' mogamulizumab fil-kura ta' pazjenti b'mycosis fungoides (MF) jew bis-sindrome ta' Sézary (SS) kienet stabbilita fi studju b'tikketta miftuħa, multiċentriku tal-Fażi 3 (0761-010) li fih ħadu sehem 372 pazjent adult randomizzati 1:1 għal kura b'jew mogamulizumab jew b'vorinostat.
English: Serious infections, including sepsis, pneumonia and skin infections, were experienced by 14.3% of subjects receiving mogamulizumab.
Maltese: Infezzjonijiet serji, inkluż sepsis, pulmonite u infezzjonijiet tal-ġilda, kienu esperjenzati minn 14.3% tal-individwi li kienu qed jirċievu mogamulizumab.
English: POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Maltese: POTELIGEO huwa indikat għat trattament ta' pazjenti adulti b'mycosis fungoides (MF) jew bissindrome ta' Sézary (SS) li talanqas ikunu ngħataw terapija sistemika waħda preċedenti.
English: POTELIGEO has not been studied in patients with severe hepatic impairment (see section 5.2).
Maltese: POTELIGEO ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 5.2).
English: Key secondary endpoints were overall response rate (ORR), ORR after crossover, duration of response (DOR), and changes from baseline of the Skindex-29 Symptoms and Functional Scales, and Functional Assessment of Cancer Therapy-General (FACT-G) Physical and Functional Well-being domains.
Maltese: Il-punti ta' tmiem sekondarji ewlenin kienu r-rata ta' rispons ġenerali (ORR), l-ORR wara l-qalba, ittul tar-rispons (DOR), u t-tibdil mil-linja bażi fuq l-Iskala tas-Sintomi u fuq l-Iskala tal-Funzjonament ta' Skindex-29, u fid-dominji tal-Benesseri Fiżiku u tal-Benesseri Funzjonali tal-Valutazzjoni Funzjonali tat-Terapija tal-Kanċer-Ġenerali (FACT-G - Functional Assessment of Cancer TherapyGeneral).
English: Complications of allogeneic hematopoietic stem cell transplantation (HSCT) after mogamulizumab Complications, including severe graft versus host disease (GVHD), have been reported in patients with T-cell lymphomas other than MF or SS who received allogeneic HSCT after mogamulizumab.
Maltese: Kumplikazzjonijiet, inkluż il-marda serja tat-trapjant kontra l-ospitant (severe graft versus host disease) (GVHD), ġew irrapportata f'pazjenti b'linfomi taċ-ċelluli-T minbarra MF jew SS li ngħataw HSCT alloġeniċi wara mogamulizumab.
English: For storage conditions after dilution of the medicinal product, see section 6.3
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3
English: Do not shake.
Maltese: (każ wieħed).
English: Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an infusion bag containing 9mg per ml (0.9%) sodium chloride solution for injection.
Maltese: B'mod asettiku iġbed il-volum meħtieġ ta' POTELIGEO fis-siringa u itfgħu ġo borża tal-infużjoni li jkun fiha soluzzjoni għall-injezzjoni ta' 9 mg ta' klorur tas-sodju kull ml (0.9%).
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi) Effikaċja
English: Overall response rate (confirmed CR + PR, %)
Maltese: Rata ta' rispons ġenerali (CR + PR ikkonfermati,
English: Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
Maltese: Tingħata darba fil-ġimgħa fil-jiem 1, 8, 15 u 22 tal-ewwel ċiklu ta' 28-jum, segwita minn infużjonijiet kull ġimgħatejn fil-Jiem 1 u 15 ta' kull ċiklu sussegwenti ta' 28-jum sakemm il-marda tipprogressa jew it-tossiċità ma tkunx aċċettabbli.
English: The exposure to mogamulizumab increased proportionally with dose over the dose range of 0.1 to 1.0 mg/kg.
Maltese: L-esponiment għal mogamulizumab żdied b'mod proporzjonali b'dożi 'l fuq mill-medda ta' dożi ta' bejn 0.1 u 1.0 mg/kg.
English: • The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
Maltese: Għoti • Is-soluzzjoni dilwita hija kompatibbli ma' boroż tal-infużjoni tal-klorur tal-polivinil (PVC) jew tal-poljolefina (PO).
English: The primary efficacy endpoint was progression-free survival (PFS) based on investigator assessment using a global composite response criteria that took into account all potentially affected disease compartments (skin, blood, lymph nodes and viscera).
Maltese: Il-punt ta' tmiem primarju li juri l-effikaċja kien is-sopravivenza mingħajr progressjoni (PFS) ibbażata fuq valutazzjoni ta' investigatur bl-użu ta' kriterji ta' rispons globali komposti li qiesu l-kompartimenti kollha potenzjalment affettwati (ġilda, demm, linfonodi u vixxri).
English: POTELIGEO 4 mg/mL concentrate for solution for infusion.
Maltese: POTELIGEO 4 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: How to store POTELIGEO
Maltese: X'fih POTELIGEO
English: Fatigue may occur following administration of mogamulizumab (see section 4.8).
Maltese: Persuni jistgħu jesperjenzaw għeja wara l-għoti ta' mogamulizumab (ara sezzjoni 4.8).
English: Based on a population PK analysis, the geometric mean (% coefficient of variation [CV%]) clearance (CL) is 12.0 mL/h (83.7%) and geometric mean elimination half-life (t1/2) is 17 days (65.5%).
Maltese: tat-tneħħija (CL) hija ta' 12.0 mL/h (83.7%) u l-medda ġeometrika tas-semiħajja metabolika (t1/2) hija ta' 17-il jum (65.5%).
English: a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region.
Maltese: Il-valur-P inkiseb mit-test Cochran-Mantel-Haenszel b'aġġustament għat-tip ta' marda, l-istadju tal-marda, u r reġjun.
English: Reporting suspected adverse reactions
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: The trial excluded patients with active autoimmune diseases, central nervous system metastasis, and medical conditions that required systemic corticosteroids or other immunosuppressive medicinal products, or an active infection requiring therapy, including HIV, or hepatitis B or C. Patients with ECOG performance status ≥2 were also excluded.
Maltese: Pazjenti b'mard awtoimmuni, b'metastasi tas-sistema nervuża ċentrali, u b'kundizzjonijiet mediċi li kienu jeħtieġu kortikosterojdi sistemiċi jew prodotti mediċinali immunosoppressivi oħra, jew b'infezzjoni attiva li kienet teħtieġ terapija, inkluż HIV, jew epatite B jew Ċ kienu esklużi mill-prova.
English: The following factors had no clinically important effect on the CL of mogamulizumab: age (range: 22 to 101 years), sex, ethnicity (other than Japanese, limited data are available in other ethnic populations), renal impairment, mild or moderate hepatic impairment, disease subtype (mycosis fungoides (MF) or Sézary Syndrome (SS)), degree of CCR4 expression or ECOG status, although it should be noted that patients with ECOG PS ≥2 were excluded from the clinical trials.
Maltese: Il-fatturi li ġejjin ma kellhom l-ebda effett klinikament importanti fuq is-CL ta' mogamulizumab: l-età (medda: 22 sa 101 sena), is-sess, l-etniċità (minbarra l-Ġappuniżi, id-data disponibbli għal popolazzjonijiet etniċi oħra hija limitata), indeboliment tal-kliewi, indeboliment tal-fwied ħafif jew moderat, is-sottotip tal-marda (mycosis fungoides (MF) jew is-Sindrome ta' Sézary (SS)), il-grad ta' espressjoni ta' CCR4 jew l-istatus tal-ECOG, għalkemm għandu jiġi nnotat li pazjenti b'ECOG PS ≥2
English: Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL.
Maltese: Kull kunjett fih 20 mg ta' mogamulizumab f'5 mL, li jikkorrispondi għal 4 mg/mL.
English: • POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4).
Maltese: • POTELIGEO għandu jitwaqqaf għal kollox f'każ ta' reazzjoni relatata mal-infużjoni ta' periklu għall-ħajja (Grad 4) (ara sezzjoni 4.4).
English: Mogamulizumab N=186
Maltese: Ġilda n=186
English: Very common Infectionsa Common
Maltese: Komuni ħafna Infezzjonijieta
English: How to store POTELIGEO Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: POTELIGEO contains sodium
Maltese: Kif jidher POTELIGEO u l-kontenut tal-pakkett
English: • The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated.
Maltese: • L-infużjoni ta' POTELIGEO għandha titwaqqaf temporanjament f'każ ta' reazzjonijiet relatati mal-infużjoni ta' bejn ħfief u severi (Gradi 1-3) u s-sintomi għandhom jiġu trattati.
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: The population PK analysis included 444 patients receiving mogamulizumab in six clinical trials.
Maltese: L-analiżi PK tal-popolazzjoni kienet tinkludi 444 pazjent li ngħataw mogamulizumab f'sitt provi kliniċi.
English: - Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL.
Maltese: - Kull kunjett fih 20 mg ta' mogamulizumab f'konċentrat ta' 5 mL, li jikkorrispondi għal 4 mg/mL.
English: Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Maltese: Mogamulizumab huwa mistenni li jiġi degradat f'peptidi u f'amminoaċidi żgħar permezz ta' passaġġi kataboliċi bl-istess mod bħal IgG endoġena.
English: Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Maltese: Reazzjonijiet avversi severi kienu jinkludu insuffiċjenza respiratorja tal-Grad 4 (1.1%) u rreazzjonijiet tal-Grad 5 kienu polimiosite u sepsis (0.5% kull waħda).
English: Response in the viscera could not be evaluated due to limited efficacy data in subjects with visceral involvement; the benefit-risk of mogamulizumab in subjects with visceral involvement is currently undetermined due to lack of data.
Maltese: Ir-rispons fil-vixxri ma setax jiġi vvalutat minħabba data limitata dwar l-effikaċja f'individwi b'involviment tal-vixxri; minħabba nuqqas ta' data l-benefiċċju riskju ta' mogamulizumab f'individwi b'involviment tal-vixxri attwalment mhuwiex determinat.
English: - allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6).
Maltese: - allerġiku/a għal mogamulizumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: Large cell transformation (LCT) There are limited data available on patients with LCT.
Maltese: Id-data disponibbli dwar pazjenti b'LCT hija limitata.
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Maltese: Fi studji dwar it-tossiċità b'dożi ripetuti fuq xadini cynomolgus ma kienu osservati l-ebda effetti avversi fuq l-organi riproduttivi tal-irġiel u tan-nisa (ara sezzjoni 5.3).
English: No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression.
Maltese: 10 individwi b'espressjoni CCR4 baxxa (<10%).