FrancophonIA/ELRC3.0 huggingface dataset:
English: At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either rituximab (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for 18 months) or azathioprine (administered orally at a dose of 2 mg/kg/day for 12 months, then 1.5 mg/kg/day for 6 months, and finally 1 mg/kg/day for 4 months (treatment discontinuation after these 22 months)).
Maltese: F'dak iż-żmien, u f'massimu ta' xahar wara l-aħħar cyclophosphamide pulse, il-pazjenti ġew assenjati b'mod każwali biex jirċievu rituximab (żewġ infużjonijiet IV ta' 500 mg ġimagħtejn bogħod minn xulxin (f'Jum 1 u Jum 15) segwiti minn 500 mg IV kull 6 xhur għal 18-il xahar) jew inkella azathioprine (mogħti mill-ħalq b'doża ta' 2 mg/kg/jum għal 12-il xahar, imbagħad 1.5 mg/kg/jum għal 6 xhur, u fl-aħħar 1 mg/kg/jum għal 4 xhur (waqfien tat-trattament wara dawn it-22 xahar)).
English: Chronic lymphocytic leukaemia
Maltese: L-Esperjenza klinika f'limfoma
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Maltese: F'xahar 24, l-estimi ta' sopravivenza globali kienu ta' 68.2% fil- grupp ta' R-CHOP ikkumparati ma' 57.4%
English: All physicians who are expected to prescribe Rixathon for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Rixathon
Maltese: - Informazzjoni dwar il-prodott - Kartuna ta' twissija tal-HCP (Health care professional - Professjonista tal-kura tas-saħħa) li tindirizza l-użu korretta ta' Rixathon
English: In studies of rituximab in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Maltese: Fi studji dwar rituximab f'pazjenti b'makroglobulinimja ta' Waldenstrom, ġew osservati żidiet temporanji fil-livelli ta' IgM fis-serum wara l-bidu tal-kura, li jistgħu jkunu assoċjati ma' viskożità eċċessiva u sintomi relatati.
English: +pancytopenia, +granulocytopenia disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy increase in serum IgM levels3
Maltese: CLL taffettwa limfoċit partikolari, iċ-ċellula B, li toriġina mill-mudullun tal-għadam u tiżviluppa fil-glandoli tallimfa.
English: Patients randomised to the standard-dose prednisone group received an initial 1 mg/kg/day oral prednisone tapered off over 12 months if they had moderate disease or 1.5 mg/kg/day oral prednisone tapered off over 18 months if they had severe disease.
Maltese: Il-pazjenti randomised għall-grupp b'doża standard ta' prednisone rċevew 1 mg/kg/jum inizjali ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 12-il xahar jekk kellhom marda moderata jew 1.5 mg/kg/jum ta' prednisone mill-ħalq li tnaqqas għax-xejn fuq perjodu ta' 18-il xahar jekk kellhom marda severa.
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or rituximab in combination with FC (R-FC).
Maltese: (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, ġranet 1-3) kull 4 ġimgħat għal 6 ċikli jew rituximab flimkien ma' FC (R-FC).
English: The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicenter trial (Trial 1).
Maltese: Esperjenza klinika f'artrite rewmatika L-effikaċja u s-sigurtà ta' rituximab fis-solliev tas-sintomi u s-sinjali tal-artrite rewmatika f'pazjenti b'rispons mhux adegwat għall-inibituri ta' TNF ġew murija fi prova pivitali randomised, ikkontrollata, double-blind, b'aktar minn ċentru wieħed (Prova 1).
English: • blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Maltese: • problemi fit-tagħqid tad-demm, tnaqqis fil-produzzjoni ta' ċelluli ħomor tad-demm u żieda fid distruzzjoni ta' ċelluli ħomor tad-demm (anemija emolitika aplastika), glandoli tal-limfa minfuħa jew imkabbra
English: Tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multiorgan failure4
Maltese: riħ, +għeja, +tregħid, +insuffiċjenza ta' ħafna organi4
English: If you respond well to treatment, you may be given Rixathon as a maintenance treatment.
Maltese: Jekk tirrispondi sew għat-trattament, għandek mnejn tingħata Rixathon bħala trattament ta' manteniment.
English: Relapsed/Refractory follicular lymphoma
Maltese: Limfoma follikulari mhux ikkurata minn qabel
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Maltese: Il-każijiet irrappurtati kellhom fatturi ta' riskju rikonoxxuti għal PRES/RPLS, inkluż il-marda tal-pazjent, pressjoni għolja, terapija immunosoppressiva u/jew kimoterapija.
English: The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24.
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti li kisbu rispons ACR20 f'ġimgħa 24.
English: Acne
Maltese: rinite
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC
Maltese: FC 19% f'CLL mhux ikkurata minn qabel), panċitopenija (R-FC 3% vs
English: Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Maltese: Esperjenza minn granulomatosi b'polianġite u polianġite mikroskopika
English: Other medicines and Rixathon
Maltese: Għalxiex jintuża Rixathon
English: At week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Maltese: F'Ġimgħa 24, pazjenti li kienu seropożittivi għal RF u/jew għallanti-CCP fil-linja bażi kellhom probabbiltà akbar b'mod sinifikanti li jilħqu rispons ACR20 u 50 meta mqabbel ma' pazjenti seronegattivi (p = 0.
English: Malignancies
Maltese: ipokalċimja
English: Hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Maltese: tnaqqis fil-piż, edima periferali, edima filwiċċ, żieda flLDH,
English: Cases of progressive multifocal leukoencephalopathy with fatal outcome have been reported following use of rituximab for the treatment of autoimmune diseases.
Maltese: lewkoenċefalopatija multifokali progressiva (PML) b'riżultat fatali.
English: The recommended dosage of Rixathon for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Maltese: Id-dożaġġ irrakkomandat ta' Rixathon għal terapija għall-induzzjoni ta' remissjoni ta' granulomatosi b'polianġite u polianġite mikroskopika hija ta' 375 mg/m2 tal-erja tas-superfiċje tal-ġisem, mogħti bħala infużjoni fil-vini darba fil-ġimgħa għal 4 ġimgħat (total ta' erba' infużjonijiet).
English: Rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Maltese: Il-pazjenti kollha fil-grupp ta' cyclophosphamide rċevew terapija ta' manteniment ta' azathioprine waqt il perjodu li fih ġew segwiti.
English: Rixathon slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Maltese: Ma kienx hemm differenzi rrappurtati għall-inċidenza ta' anemija.
English: Rixathon is used for the treatment of rheumatoid arthritis.
Maltese: ċ) Artrite Rewmatika Rixathon jintuża għall-kura tal-artrite rewmatika.
English: Prednisone tapering was to be completed by 6 months from the start of trial treatment.
Maltese: It-tnaqqis bil-mod ta' prednisone kellu jitlesta sa 6 xhur wara l-bidu tal-kura tal-prova.
English: Alopecia Pruritus Urticaria Skin disorder
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi
English: The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Maltese: L-aktar infezzjoni serja rrappurtata b'mod komuni fil-grupp ta' rituximab kienet bronkite ħafifa jew moderata.
English: Peripheral neuropathy , facial nerve palsy5
Maltese: Newropatija periferali, paralisi tannerv tal-wiċċ5
English: Patients randomised to the rituximab group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Maltese: Il-pazjenti randomised għall-grupp ta' rituximab rċevew 1000 mg IV inizjali fil-Jum 1 tal-Istudju u t-tieni 1000 mg IV fil-Jum 15 tal
English: • being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
Maltese: • rimettar, dijarea, uġigħ fl-istonku, irritazzjoni jew ulċeri fil-griżmejn u fil-ħalq, problemi biex tibla', stitikezza, indiġestjoni
English: Rixathon 500 mg concentrate for solution for infusion Each 50 mL vial contains 500 mg of rituximab.
Maltese: Kull kunjett ta' 50 mL fih 500 mg ta' rituximab.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma and chronic lymphocytic leukaemia.
Maltese: Esperjenza limitata b'dożi ogħla mid-doża approvata tal-formulazzjoni għall-għoti fil-vini ta' rituximab hija disponibbli minn provi kliniċi fuq il-bnedmin.
English: This medicinal product contains 2.3 mmol (52.6 mg) sodium per 10 mL vial.
Maltese: Din il-mediċina fiha 2.3 mmol (jew 52.6 mg) ta' sodium f'kull kunjett ta' 10 mL.
English: Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Maltese: Pazjenti b'seroloġija pożittiva għall-epatite B (HBsAg jew HBcAb) għandhom jikkonsultaw esperti tal-mard tal-fwied qabel ma tinbeda l-kura u għandhom jiġu mmonitorjati u mmaniġjati skont standards mediċi lokali biex tiġi evitata attivazzjoni mill-ġdid tal-epatite B.
English: A Patient Alert Card will be included in the carton.
Maltese: Kartuna ta' Twissija għall-Pazjent ser tkun inkluża fil-kartuna.
English: Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Maltese: Ibbażat fuq il-mekkaniżmu ta' azzjoni ta' rituximab u l-għarfien li ċ-ċelluli B għandhom rwol importanti fiż-żamma ta' rispons immuni normali, il-pazjenti jkollhom riskju akbar ta' infezzjoni wara terapija b'rituximab (ara sezzjoni 5.1).
English: B cell levels in human neonates following maternal exposure to rituximab have not been studied in clinical trials.
Maltese: Il-livelli taċ-ċellula B fi trabi umani tat-twelid wara l-esponiment tal-omm għal rituximab ma ġewx studjati fi provi kliniċi.
English: , leucopenia, +febrile neutropenia, +thrombocyt openia
Maltese: Newtropenija, lewkopenija, +newtropenija bid-deni,
English: Malignancy
Maltese: Sturdament
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Maltese: li reġgħet tfaċċat/refrattarja (3% R-FC, 3% FC).
English: Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Maltese: L-irbit ta' Rituximab mal-antiġen CD 20 fuq il-limfoċiti B wera wkoll li jwassal għall-mewt taċ-ċelluli permezz ta' apoptosi.
English: Rituximab is associated with infusion related reactions (IRRs), which may be related to release of cytokines and/or other chemical mediators.
Maltese: Rituximab huwa assoċjat ma' reazzjonijiet relatati mal-infużjoni (IRRs), li jistgħu jkunu relatati marreħa ta' ċitokini u/jew medjaturi kimiċi oħra.
English: The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas.
Maltese: L-antiġen huwa espress fuq > 95% tal-limfomi mhux ta'
English: • nose bleeds
Maltese: • tħossok sturdut
English: Rituximab was detectable in the serum of patients 3 to 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: However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted postnatally and was accompanied by a decrease in IgG level in the newborn animals affected.
Maltese: Madankollu, kien osservat tnaqqis farmakoloġiku dipendenti fuq id-doża taċ-ċelluli B fl-organi limfojdi tal-feti, li ppersista wara t-twelid u kien akkumpanjat bi tnaqqis fil-livell ta' IgG fl-annimali tat-twelid affettwati.
English: Hyperkalaemia
Maltese: Korsijiet multipli
English: Measure blood neutrophils prior to each course of Rixathon, 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' Rixathon, u b'mod regolari għal perjodu sa 6 xhur wara l-waqfien tal-kura, u meta jkun hemm sinjali jew sintomi ta' infezzjoni (ara sezzjoni 4.8).
English: EU/1/19/1371/001 Ultomiris
Maltese: EU/1/19/1371/001 Ultomiris 300 mg
English: 30 ml (10 mg/ml) 1 vial
Maltese: 30ml (10mg/ml)
English: MA (EU)-number (Invented) Name Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU)
English: 300 mg Concentrate for solution for infusion
Maltese: Konċentrat għal soluzzjoni għallinfużjoni
English: EU number
Maltese: Numru tal-EU
English: Ref. EMEA/544525/2008
Maltese: EMEA/180894/2009
English: International non-proprietary name (INN): desvenlafaxine
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): desvenlafaxine
English: What is Ellefore?
Maltese: X'inhu Ellefore?
English: It was to be available as prolonged-release tablets (50, 100 and 200 mg).
Maltese: Kellu jkun disponibbli bħala pilloli li jerħu fit-tul (50, 100 u 200 mg).
English: Ellefore is a medicine that contains the active substance desvenlafaxine.
Maltese: Ellefore huwa mediċina li fiha s-sustanza attiva desvenlafaxine.
English: The active substance in Ellefore, desvenlafaxine, is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI).
Maltese: Is-sustanza attiva f'Ellefore, desvenlafaxine, hija ‘inibitur ta' teħid mill-ġdid ta' serotonina u noradrenalina' (SNRI).
English: In relation to its parent substance, venlafaxine, desvenlafaxine seemed to be less effective with no advantages in terms of safety and tolerability.
Maltese: Meta mqabbla mas-sustanza omm tiegħu, venlafaxine, desvenlafaxine deher li kien inqas effettiv mingħajr vantaġġi f'termini ta' sigurtà u tollerabilità.
English: Ellefore was compared with placebo (a dummy treatment) in nine main studies involving a total of over 3,000 adults with major depression.
Maltese: Ellefore tqabbel ma' plaċebo (trattament finta) f'disa' studji prinċipali li jinvolvu total ta' aktar minn 3,000 adulti b'dipressjoni maġġuri.
English: On 13 October 2008, Wyeth Europa Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ellefore, for the treatment of major depressive disorder.
Maltese: Fit-13 ta' Ottubru 2008, Wyeth Europa Ltd. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Ellefore, għat-trattament ta' disturbi ta' dipressjoni maġġuri.
English: Four of the studies involving 1,814 patients used a fixed dose of Ellefore, and another four involving 1,229 patients used doses of Ellefore that could be adjusted.
Maltese: Erba' mill-istudji li kienu jinvolvu 1,814-il pazjent użaw doża fissa ta' Ellefore, u erbgħa oħrajn li kienu jinvolvu 1,229 pazjent, użaw dożi ta' Ellefore li jistgħu jiġu aġġustati.
English: Desvenlafaxine is derived from venlafaxine, an SNRI that has been used as an antidepressant since the 1990s.
Maltese: Desvenlafaxine huwa derivat minn venlafaxine, SNRI li ilu jintuża bħala antidepressiv sa mis-snin disgħin.
English: The CHMP was assessing the responses given by the company to a list of questions.
Maltese: Is-CHMP kien qiegħed jevalwa ttweġibiet mogħtija mill-kumpanija għal lista ta' mistoqsijiet.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain.
Maltese: Taħdem billi timpedixxi lin-newrotrasmettituri 5-hydroxytryptamine (magħrufin ukoll bħala serotonina) u noradrenalina milli jittieħdu mill-ġdid lura miċ-ċelloli tannervituri fil-moħħ.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Abbażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-jum 120, li mbagħad tintbagħat lill-kumpanija.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: Newrotrasmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: Two of the flexible-dose studies also included venlafaxine (however, the studies were not designed to compare the two medicines).
Maltese: Tnejn mill-istudji b'doża flessibbli inkludew ukoll venlafaxine (madankollu, l-istudji ma ġewx imfassla biex iqabblu ż-żewġ mediċini).
English: The application was at day 166 when the company withdrew.
Maltese: L-applikazzjoni kienet f'jum 166 meta l-kumpanija rtiratha.
English: How is Ellefore expected to work?
Maltese: Kif huwa mistenni li jaħdem Ellefore?
English: Ellefore was expected to be used to treat major depression in adults.
Maltese: Ellefore kien mistenni li jintuża biex jittratta dipressjoni maġġuri fl-adulti.
English: The effects of Ellefore were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Ellefore ġew ittestjati għall-ewwel darba f'mudelli esperimentali qabel ma ġew studjati fuq il-bnedmin.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ellefore had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Maltese: Għalhekk, fi żmien l-irtirar, is-CHMP kien tal-opinjoni li l-benefiċċju ta' Ellefore ma ntwerietx b'mod suffiċjenti u kwalunkwe benefiċċju ma kienx jegħleb ir-riskji identifikati.
English: Questions and answers on the withdrawal of the marketing application for Ellefore
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Ellefore
English: The substance has been slightly modified with the aim of reducing side effects in patients who have problems breaking venlafaxine down.
Maltese: Is-sustanza ġiet immodifikata kemmxejn bil-għan li jitnaqqsu l-effetti sekondarji f'pazjenti li għandhom problemi fit-tkissir ta' venlafaxine.
English: What was Ellefore expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Ellefore?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ellefore and that there are no compassionate use programmes ongoing.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kienx hemm konsegwenzi għall-pazjenti li fil-preżent huma inklużi fi provi kliniċi b'Ellefore u ma hemm ebda programm ta' użu ta' b'kumpassjoni għaddej.
English: In all of the studies, the effectiveness of the medicine was measured using standard questionnaires for depression.
Maltese: Fl-istudji kollha, l-effikaċja tal-mediċina tkejlet permezz ta' kwestjonarji standard għad-dipressjoni.
English: The CHMP was concerned that, overall, the effectiveness of Ellefore had not been shown convincingly.
Maltese: Is-CHMP kien imħasseb li, b'mod ġenerali, l-effikaċja ta' Ellefore ma ntwerietx b'mod konvinċenti.
English: Distribution/Elimination
Maltese: Distribuzzjoni/Eliminazzjoni
English: In total: 8 cycles.
Maltese: Total: 8 ċikli.
English: − CI = confidence interval.
Maltese: − CI = intervall ta' kunfidenza.
English: Part 2 N = 176
Maltese: Parti 2 N = 176
English: Trial BP22333 (SparkThera)
Maltese: Prova BP22333 (SparkThera)
English: by Q4 2019 (preliminary CSR) by Q4 2020 (final CSR)
Maltese: sa Q4 2019 (CSR preliminari) sa Q4 2020
English: Trial BO22334 (SABRINA)
Maltese: Prova BO22334 (SABRINA)
English: Median TTF/PFS/ EFS mo
Maltese: TTF/PFS/EFS
English: Binet stage A Binet stage B Binet stage C
Maltese: Stadju binet A Stadju binet B Stadju binet Ċ
English: Non-oncology indications:
Maltese: Indikazzjonijiet mhux onkoloġiċi:
English: Date of latest renewal: 2 June 2008
Maltese: Data tal-aħħar tiġdid: 2 ta' Ġunju 2008
English: • The active ingredient is rituximab.
Maltese: • Is-sustanza attiva hi rituximab.
English: Final analysis (median FU: 9.0 years)
Maltese: Analiżi finali (FU medjan: 9.0 snin)
English: The total number of cycles is of 6.
Maltese: In-numru totali ta' ċikli huwa ta' 6.
English: The corresponding AUCτ ratios were 1.66, 1.17 and 1.32.
Maltese: Il-proporzjonijiet ta' AUCτ li jikkorrispondu kienu ta' 1.66, 1.17 u 1.32.
English: Mean change DAS28-ESR -1.97**
Maltese: Bidla medja f'DAS28-ESR -1.97**
English: Bronchitis, sinusitis, gastroenteritis, tinea pedis
Maltese: Bronkite, sinożite, gastro-enterite, tinea pedis
English: Observation (N = 167)
Maltese: Osservazzjo ni (N = 167)
English: MabThera contains the active substance “rituximab”.
Maltese: MabThera fih is-sustanza attiva “rituximab”.
English: Log-Rank p value
Maltese: Log-Rank valur p
English: p-value (Wald test, not adjusted)
Maltese: valur p (test ta' Wald, mhux aġġustat)
English: Table 7: Trial BP22333 (SparkThera): Absorption - Pharmacokinetic parameters of MabThera SC compared to MabThera IV
Maltese: Prova BP22333 (SparkThera): Assorbiment - Parametri farmakokinetiċi ta' MabThera SC imqabbla ma' MabThera IV
English: 6 Contents of the pack and other information
Maltese: 6 Kontenut tal-pakkett u informazzjoni oħra
English: 24-hours after infusion
Maltese: 24 siegħa wara infużjoni
English: MabThera maintenance treatment reduced the risk of death by 56 % (95 % CI; 22 %-75 %).
Maltese: Kura ta' manteniment b'MabThera naqqset ir-riskju ta' mewt b'56 % (CI ta' 95 %; 22 %-75 %).
English: lung infiltration,
Maltese: Infiltrati fil-pulmun,
English: MabThera 500 mg concentrate for solution for infusion EU/1/98/067/002
Maltese: MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni EU/1/98/067/002
English: See Section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku.
English: • Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Maltese: • Lewkimja limfoċitika kronika (CLL - chronic lymphocytic leukaemia) hija l-aktar forma komuni ta' lewkimja fl-adulti.
English: Neutropenia
Maltese: Irritabilità
English: 1 Antibody Way Oceanside, CA 92056 5802 USA
Maltese: Oceanside, CA 92056 5802 L-ISTATI
English: % SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID
Maltese: MHS SF-36 MHS MCID %
English: Based on popPK analysis of study BO25341 (SAWYER) an absolute bioavailability of 68.4% was estimated.
Maltese: Abbażi ta' analiżi tal-PK tal-popolazzjoni ta' studju BO25341 (SAWYER) ġiet stmata bijodisponibilità assoluta ta' 68.4%.
English: • The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.
Maltese: • Is-sustanzi l-oħra huma hyaluronidase rikombinanti uman (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 u ilma għall-injezzjonijiet.