FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of MabThera (Figure 4).
Maltese: In-numru ta' pazjenti li jirċievu rituximab flimkien ma' doża baxxa ta' prednisone mingħajr terapija bi prednisone jew fuq terapija minima (doża ta' prednisone ta' 10 mg jew inqas kuljum) meta mqabbla ma' pazjenti li jirċievu prednisone b'doża standard matul il-perjodu ta' trattament ta' 24 xahar juri effett ta' MabThera li jnaqqas l-użu ta' sterojdi (Figura 4).
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%.
Maltese: Stimi Kaplan Meier tat-tul medjan ta' sopravivenza mingħajr avvenimenti kienu ta' 35 xahar fil-grupp ta' R-CHOP imqabbel ma' 13-il xahar fil-grupp ta' CHOP, li jirrappreżentaw tnaqqis fir-riskju ta' 41 %.
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Maltese: L-antikorp huwa magħmul permezz ta' koltura ta' suspensjoni ta' ċelluli mammiferi (ovarju tal-ħamster Ċiniż) u ppurifikat bi kromatografija tal-affinità u skambju tal-jone, inkluża l-inattivazzjoni virali speċifika u proċeduri tat-tneħħija.
English: Ctrough values at pre-dose cycle 8
Maltese: Remissjoni kompluta wara 12 u 18-il xahar
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.
Maltese: Hemm disponibbli data limitata biss dwar l-effikaċja u s-sigurtà għall-pazjenti ttrattati qabel b'antikorpi monoklonali inkluż MabThera jew pazjenti li ma rrispondewx għal trattament minn qabel ta' MabThera flimkien ma' kimoterapija.
English: R--FC (N=276)
Maltese: Anti-CCP -ve u RF -ve (N=116)
English: NR: not reached; a: only applicable to patients achieving a CR
Maltese: NR: ma ntlaħaqx; a: japplika biss għall-pazjenti li kisbu CR
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/067/002
English: MabThera N=505
Maltese: N=505
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,600 mg/13.4 mL
Maltese: INDIVIDWALI 1,600 mg/13.4 mL
English: Infections and infestations Bronchitis Rhinitis General disorders and administration site conditions Pyrexia Influenza-like illness Oedema peripheral Gastrointestinal disorders Diarrhoea Respiratory, thoracic and mediastinal disorders Dyspnoea Injury, poisoning and procedural complications Infusion-related reactions 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Maltese: Disturbi gastro-intestinali Dijarea Disturbi respiratorji, toraċiċi u medjastinali Qtugħ ta' nifs Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Reazzjonijiet relatati mal-infużjoni Avvenimenti kienu kkunsidrati bħala ADRs biss wara valutazzjoni bir-reqqa u fejn relazzjoni kawżali bejn il-prodott mediċinali u l-avveniment avvers kienet mill-inqas possibbiltà raġonevoli.
English: The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray.
Maltese: Insuffiċjenza respiratorja akuta tista' tkun akkompanjata minn avvenimenti bħal infiltrazzjoni fl-interstizju tal-pulmun jew edima, li jidhru fuq X-ray tas-sider.
English: Patients randomised to the MabThera group received an initial intravenous infusion of 1000 mg MabThera on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Maltese: Il-pazjenti randomised għall-grupp ta' MabThera rċevew infużjoni inizjali fil-vini ta' 1000 mg MabThera fil-Jum 1 tal-Istudju flimkien ma' 0.5 mg/kg/jum ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 3 xhur jekk kellhom marda moderata jew 1 mg/kg/jum ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 6 xhur jekk kellhom marda severa, u t-tieni infużjoni fil-vini ta' 1000 mg fil-Jum 15 tal-Istudju.
English: Overall response rate* chi-squared test p value odds ratio (95% CI)
Maltese: Rata ta' rispons komplut (CR/CRu)* valur p minn test chi-squared
English: 38 months
Maltese: 38 xahar
English: There is no evidence of dysmorphogenesis (i.e. teratogenesis) resulting from systemic exposure to rHuPH20.
Maltese: M'hemm l-ebda evidenza ta' dismorfoġenesi (jiġifieri teratoġenesi) ikkawżata minn esponiment sistemiku għal rHuPH20.
English: MabThera subcutaneous formulation MabThera intravenous formulation
Maltese: Reazzjonijiet avversi rrappurtati bl-użu tal-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera
English: Administration related reactions have been observed in up to 50% of patients treated with MabThera subcutaneous formulation in clinical trials.
Maltese: Reazzjonijiet relatati mal-għoti kienu osservati f'sa 50% tal-pazjenti kkurati bil-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera fil-provi kliniċi.
English: Immunogenicity
Maltese: Immunoglobulini
English: There was no apparent impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety or efficacy.
Maltese: Ma kien hemm l-ebda impatt evidenti tal-preżenza ta' antikorpi kontra rituximab jew kontra rHuPH20 fuq is-sigurtà jew l-effikaċja.
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of
Maltese: F'xahar 24, l-estimi ta' sopravivenza globali kienu ta' 68.2% fil-grupp ta' R-CHOP ikkumparati ma' 57.4% fil grupp ta' CHOP. Analiżi sussegwenti tat-tul tas-sopravivenza globali, imwettqa b'tul ta' żmien medjan ta' segwitu ta' 60 xahar, ikkonfermat il-benefiċċju tal-kura R-CHOP fuq dik CHOP (p=0.0071), li tirrappreżenta tnaqqis ta'
English: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Maltese: • infezzjonijiet fid-demm (sepsi), pnewmonja, ħruq ta' Sant Antnin, riħ, infezzjonijiet fit-tubi tal-bronki, infezzjonijiet ikkawżati mill-moffa, infezzjonijiet ta' oriġini mhux magħrufa, infjammazzjoni tas-sinus, epatite B
English: Infusion-related reactions
Maltese: Reazzjonijiet relatati mal-infużjon anġjoedima
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
Maltese: Il-farmakokinetika ta' rituximab kienet evalwata wara żewġ dożi IV ta' 500 mg u 1000 mg ma' kura mill-ġdid fit-tieni kors. Cmax medja għal rituximab fis-serum wara l-ewwel infużjoni kienet ta' 170 sa 175 µg/mL għad-doża ta' 2 x 500 mg u 317 sa 370 µg/mL għad-doża ta' 2 x 1000 mg. Cmax wara t-tieni infużjoni, kienet ta' 207 µg/mL għad-doża ta' 2 x 500 mg u varjat minn 377 sa 386 µg/mL għad-doża ta' 2 x 1000 mg.
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at 3 month follow-up visit (Part 2) b - at time of final analysis (median follow-up 53 months)
Maltese: PFS - Sopravivenza Mingħajr Progressjoni (Progression-Free Survival) (proporzjon b'avveniment, progressjoni/irkadar talmarda jew mewt minn kwalunkwe kawża) a - fiż-żjara ta' segwitu wara 3 xhur (Parti 2)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vial of 10 mL (10 mg/mL)
Maltese: Kunjett ta' 10 mL (10 mg/mL)
English: Results from other supportive studies using MabThera in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Maltese: Riżultati minn studji oħra ta' sapport bl-użu ta' MabThera flimkien ma' korsijiet oħra ta' kimoterapija (inkluż CHOP, FCM, PC, PCM, bendamustine u cladribine) għall-kura ta' pazjenti b'CLL mhux ikkurata minn qabel u/jew li reġgħet tfaċċat/refrattarja ukoll urew rati ta' rispons globali għolja b'benefiċċju f'termini ta' rati ta' PFS, għalkemm b'tossiċità kemmxejn ogħla (speċjalment majelotossiċità).
English: The prepared MabThera solution should be administered as an intravenous infusion through a dedicated line.
Maltese: MabThera kien amministrat fl-ewwel ġurnata taċ-ċiklu ta' kura.
English: Measure blood neutrophils prior to each course of MabThera, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Maltese: Kejjel in-newtrofili fid-demm qabel kull kors ta' MabThera, u b'mod regolari għal perijodu sa 6 xhur wara l-waqfien tal-kura, u meta jkun hemm sinjali jew sintomi ta' infezzjoni (ara sezzjoni 4.8).
English: Gastrointestinal perforation in some cases leading to death has been observed in patients receiving MabThera for treatment of Non-Hodgkin's lymphoma (NHL).
Maltese: Perforazzjoni gastro-intestinali li f'xi każijiet wasslet għall-mewt kienet osservata f'pazjenti li rċevew MabThera għall-kura ta' limfoma mhux ta' Hodgkin (NHL - Non-Hodgkin's lymphoma).
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of MabThera as a single agent or in combination with CHOP therapy (applied MabThera doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni f'298 pazjent b'NHL li rċevew infużjonijiet singoli jew multipli ta' MabThera bħala sustanza waħedha jew flimkien ma' terapija CHOP (id-dożi ta' MabThera applikati varjaw minn 100 sa 500 mg/m2), l-estimi tipiċi tal-popolazzjoni tat-tneħħija mhux speċifika (CL1), tat-tneħħija speċifika (CL2) probabbli kkontribwita minn ċelluli B jew mill-massa tat-tumur, u tal-volum ta' distribuzzjoni fil-kompartiment ċentrali (V1) kienu ta' 0.14
English: Samsung BioLogics
Maltese: Korsijiet multipli
English: No PK/clinical data are available in patients with a refractory or relapsing disease.
Maltese: Mhux disponibbli data PK/klinika f'pazjenti b'marda li ma rrispondietx għat-trattament jew li reġgħet tfaċċat.
English: During this time, 81% of patients, from the original placebo group received MabThera between weeks 24 and 56, under an open label extension study protocol.
Maltese: F'dan iż-żmien, 81 % tal-pazjenti mill-grupp oriġinali fuq il-plaċebo rċevew MabThera bejn ġimgħa 24 u ġimgħa 56, taħt protokoll ta' studju ta' estensjoni tat-tip open label.
English: Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
Maltese: F'pazjenti li kienu qed jirċievu il-formulazzjoni għall-għoti fil-vini ta' MabThera kienu rrappurtati każijiet ta' attivazzjoni mill-ġdid tal-epatite B, inkluż epatite fulminanti b'riżultat fatali.
English: Arthralgia
Maltese: Urtikarja
English: The most common local cutaneous reactions in the MabThera subcutaneous arm were injection site erythema (13%), injection site pain (7%), and injection site oedema (4%).
Maltese: L-aktar reazzjonijiet lokali fil-ġilda komuni fil-grupp ta' MabThera mogħti taħt il-ġilda kienu eritema fis-sit tal-injezzjoni (13%), uġigħ fis-sit tal-injezzjoni (7%), u edima fis-sit tal-injezzjoni (4%).
English: The clinical experience of MabThera subcutaneous formulation in Non-Hodgkin's lymphoma is based on data from a phase III clinical trial (SABRINA BO22334) in patients with follicular lymphoma (FL) and a phase Ib dose-finding/dose-confirmation trial (SparkThera BP22333) in patients with FL.
Maltese: III (SABRINA BO22334) f'pazjenti b'limfoma follikulari (FL - follicular lymphoma) u prova ta' fażi
English: • Severe vision loss (sign of brain nerves damage).
Maltese: • telf sever tal-vista (sinjal ta' ħsara fin-nervaturi tal-moħħ).
English: 5 How to store MabThera
Maltese: X'fih MabThera
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vial of 50 mL (10 mg/mL)
Maltese: Kunjett ta' 50 mL (10 mg/mL)
English: • Headache
Maltese: • stitikezza
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of MabThera and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Maltese: Użu konkomitanti/sekwenzjali ta' DMARDs oħra f'artrite rewmatika L-użu konkomitanti ta' MabThera u terapiji anti-rewmatiċi għajr dawk speċifikati taħt l-indikazzjoni u l-pożoloġija għall-artrite rewmatika mhux rakkomandat.
English: Bronchitis
Maltese: Pożoloġija
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), grade 3/4 neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), grade 3/4 pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Maltese: F'CLL, l-inċidenza globali ta' disturbi tal-qalb ta' grad 3 jew 4 kienet baxxa kemm fl-istudju primarju (4% R-FC, 3% FC) kif ukoll fl-istudju dwar CLL li reġgħet tfaċċat/ma rrispondietx għat-trattament (4% R-FC, 4% FC).
English: NAME OF THE MEDICINAL PRODUCT MabThera 100 mg concentrate for solution for infusion Rituximab
Maltese: MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni Rituximab
English: Overall the results confirm that MabThera subcutaneous formulation 1600 mg has a comparable benefit/risk profile to that of MabThera intravenous formulation 500 mg/m2.
Maltese: B'mod globali r-riżultati kkonfermaw li l-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera 1600 mg għandha profil ta' benefiċċju/riskju komparabbli ma' dak tal-formulazzjoni għall-għoti fil-vini ta' MabThera 500 mg/m
English: Table 2a First--line treatment of chronic lymphocytic leukaemia Overview of efficacy results for MabThera plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Maltese: FC waħdu - perijodu medjan ta' osservazzjoni ta' 48.1 xahar Parametru tal-Effikaċja
English: Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment.
Maltese: Rituximab kien osservat fis-serum ta' pazjenti 3 - 6 xhur wara t-tmiem tal-aħħar kura.
English: Your doctor or nurse will place the sticker on the syringe before injection.
Maltese: Medikazzjoni minn qabel bi glukokortikojdi għandha tiġi kkunsidrata wkoll.
English: • muscle twitches or shakiness
Maltese: .8 Effetti mhux mixtieqa
English: If a patient develops PML, the dosing of MabThera must be permanently discontinued.
Maltese: PML, id-dożaġġ ta' MabThera għandu jitwaqqaf b'mod permanenti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/067/003
English: The pharmacokinetic profile of MabThera when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with MabThera alone.
Maltese: Il-profil farmakokinetiku ta' MabThera meta mogħti bħala 6 infużjonijiet ta' 375 mg/m flimkien ma'
English: A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in paediatric patients treated with MabThera, in some cases severe and requiring long-term immunoglobulin substitution therapy.
Maltese: Numru żgħir ta' każijiet spontanji u fil-letteratura ta' ipogammaglobulinemija kienu osservati f'pazjenti pedjatriċi kkurati b'MabThera, f'xi każijiet severi u li jeħtieġu terapija fit-tul ta' sostituzzjoni tal-immunoglobulina.
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Maltese: • inti allerġiku għal rituximab, proteini oħrajn li huma simili għal rituximab, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6)
English: No incompatibilities between MabThera subcutaneous formulation and polypropylene or polycarbonate syringe material or stainless steel transfer and injection needles and polyethylene Luer cone stoppers have been observed.
Maltese: Ma kinux osservati inkompatibbiltajiet bejn il-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera u l-materjal polypropylene jew polycarbonate tas-siringa jew trasferiment ta' stainless steel u labar tal-injezzjoni u tappijiet Luer cone tal-polyethylene.
English: Body system Adverse event
Maltese: 1 Antibody Way
English: ORR2)
Maltese: Rogħda
English: Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients (> 70 years of age), however sample sizes were small.
Maltese: Analiżi esploratorja tal-benefiċċju ta' kura ta' manteniment wera effett anqas evidenti f'pazjenti anzjani (> 70 sena), madankollu id-daqsijiet tal-kampjuni kienu żgħar.
English: MabThera subcutaneous formulation was given at a fixed dose of 1400 mg.
Maltese: Il-formulazzjoni għall-għoti taħt il-ġilda ta' MabThera ingħatat b'doża fissa ta' 1400 mg.
English: Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving MabThera (see Section 4.4).
Maltese: Attivazzjoni mill-ġdid ta' infezzjoni tal-epatite B kienet irrappurtata wkoll b'mod rari ħafna f'pazjenti b'RA li kienu qed jirċievu MabThera (ara Sezzjoni 4.4).
English: Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in CLL (see section 4.8).
Maltese: Każijiet rari ħafna ta' PML kienu rrappurtati waqt l-użu ta' wara t-tqegħid fis-suq tal-formulazzjoni għall-għoti fil-vini ta' MabThera f'CLL (ara sezzjoni 4.8).
English: Metabolism and nutrition disorders hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Maltese: Ipergliċemija, tnaqqis fil-piż, edima periferali, edima fil-wiċċ, żjieda fl-LDH, ipokalċimja
English: Skin and subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, Stevens-Johns on syndrome toxic epidermal necrolysis (Lyell's syndrome) 7
Maltese: Reazzjonijie t bl-imsiemer severi fil-ġilda, sindrome ta' Stevens-Joh nson, nekrolisi tossika tal-epidermi de (sindrome ta' Lyell)
English: Duration of response * Disease free survival (DFS)** Time to new CLL treatment
Maltese: Treatment Group: = Grupp ta' Trattament Number of Patients = Numru ta' Pazjenti Day = Jum
English: Musculoskeletal pain Pain in extremities
Maltese: Disturbi Muskoluskeletriċi u tat-Tessuti
English: • hearing loss, loss of other senses.
Maltese: • telf ta' smigħ, telf ta' sensi oħra.
English: The percentage of patients reporting ADRs upon re-treatment with further courses of MabThera was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Maltese: Il-persentaġġ ta' pazjenti li rrappurtaw ADRs wara kura mill-ġdid b'aktar korsijiet ta' MabThera kien simili għall-persentaġġ ta' pazjenti li rrappurtaw ADRs wara li kienu esposti fil-bidu (kwalunkwe grad ta' ADRs u ADRs ta' grad 3/4).
English: Subcutaneous injections
Maltese: Indikazzjonijiet kollha
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving MabThera for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Maltese: Tabella 4 Reazzjonijiet avversi tal-mediċina li seħħew f'≥ 5% tal-pazjenti li rċevew MabThera għal trattament ta' manteniment ta' GPA u MPA, u bi frekwenza ogħla mill-grupp ta' paragun Klassi tas-Sistemi u tal-Organi Reazzjoni avversa tal-mediċina1
English: Immune system disorders infusion related reactions4, angioedema hypersensitivity anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytopenia
Maltese: Kienu rrappurtati każijiet ta' sindrome ta' enċefalopatija posterjuri riversibbli (PRES - posterior reversible encephalopathy syndrome) / sindrome ta' lewkoenċefalopatija posterjuri riversibbli
English: Of 67 patients evaluated for HAMA, no responses were noted.
Maltese: Minn 67 pazjent evalwati għal HAMA, ma kien innotat l-ebda rispons.
English: Trial
Maltese: Ttrattata)
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during postmarketing surveillance occurring in patients with rheumatoid arthritis receiving MabThera
Maltese: Tabella 2 Sommarju ta' reazzjonijiet avversi tal-mediċina rrappurtati fi provi kliniċi jew waqt sorveljanza ta' wara t-tqegħid fis-suq li seħħew f'pazjenti b'artrite rewmatika li kienu qed jirċievu MabThera
English: Neurologic disorders
Maltese: Disturbi Psikjatriċi
English: Sodium MabThera 1400 mg contains less than 1 mmol sodium per dose, i.e. it is essentially sodium-free.
Maltese: MabThera 1400 mg fih inqas minn 1 mmol ta' sodium f'kull doża, jiġifieri huwa essenzjalment mingħajr sodium.
English: MabThera infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Maltese: L-infużjonijiet ta' MabThera ngħataw wara infużjoni fil-vini ta' 100 mg methylprednisolone; il-pazjenti rċevew ukoll kura bi prednisone orali għal 15-il jum.
English: The recommended dose is: first cycle, MabThera intravenous formulation: 375 mg/m2 body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle.
Maltese: Il-formulazzjoni għall-għoti fil-vini ta' MabThera kienet użata fid-doża standard ta' 375 mg/m tal-erja tas-superfiċe tal-ġisem.
English: • MabThera intravenous (n= 88); 1st cycle of MabThera intravenous 375 mg/m2 in combination with chemotherapy followed by up to 5 cycles of MabThera intravenous 500 mg/m2 in combination with chemotherapy.
Maltese: • MabThera fil-vini (n= 88); l-ewwel ċiklu ta' MabThera 375 mg/m fil-vini flimkien ma'
English: MabThera is associated with infusion related reactions (IRRs), which may be related to release of cytokines and/or other chemical mediators.
Maltese: MabThera huwa assoċjat ma' reazzjonijiet relatati mal-infużjoni (IRRs), li jistgħu jkunu relatati mar-reħa ta' ċitokini u/jew medjaturi kimiċi oħra.
English: Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Maltese: Newropatija periferali, paralisitan-ner v tal-wiċċ5
English: EMA/350414/2010 EMEA/H/C/000073
Maltese: EMEA/H/C/000073
English: Other information about Taxotere
Maltese: Informazzjoni oħra dwar Taxotere
English: Further information on Taxotere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/taxotere.
Maltese: Aktar informazzjoni dwar Taxotere tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/taxotere.
English: Taxotere received a marketing authorisation valid throughout the EU on 27 November 1995.
Maltese: Taxotere rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-27 ta' Novembru 1995.
English: Taxotere has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-lungcancer patients, around 2,700 prostate cancer patients, 457 gastric adenocarcinoma patients and 897 head- and neck-cancer patients.
Maltese: Taxotere ġie studjat f'aktar minn 4 000 pazjent bil-kanċer tas-sider, madwar 2 000 pazjent b'kanċer tal-pulmun b'ċelloli mhux żgħar, 2,700 pazjent b'kanċer fil-prostata, 457 pazjent b'adenokarċinoma gastrika u 897 pazjent b'kanċer fir-ras u fl-għonq.