FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Maltese: Fl-adulti, l-iktar effetti sekondarji komuni bi PegIntron (li dehru f'iktar minn pazjent wieħed minn kull 10) huma infezzjoni virali, farinġite (griżmejn xotti), anemija (għedud baxxi ta' ċelloli ħomor tad-demm), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), telf tal-aptit, depressjoni, ansjetà, tibdil fil-burdata, konċentrazzjoni mdgħajfa, insomnja (diffikultà fl-irqad), uġigħ ta' ras, sturdament, dispneja (diffikultà fit-teħid tan-nifs), sogħla, rimettar, dardir, uġigħ addominali (uġigħ flistonku), dijarea, ħalq xott, alopeċja (telf ta' xagħar), prurite (ħakk), ġilda xotta, raxx, mijalġija (uġigħ fil-muskoli), artralġija (uġigħ fil-ġogi), uġigħ muskuloskeletali (fil-muskoli u fl-għadam), reazzjonijiet fis-sit tal-injezzjoni, infjammazzjoni fil-post tal-injezzjoni, għejja, astenja (djgħufija), irritabbiltà, tertir, pireksja (deni), mard simili għall-influwenza u telf ta' piż.
English: In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Maltese: Fl-adulti, jintuża fi trattamenti mħallta f'doża ta' 1.5 mikrogrammi għal kull kilogramma li jiżen il-pazjent, jew waħdu f'0.5 jew 1.0 mikrogrammi/kg.
English: This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) għal PegIntron.
English: The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Maltese: L-interferon alfa-2b f'PegIntron huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': isir minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi interferon alfa-2b.
English: In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'PegIntron, l-interferon alfa-2b ġie ‘pegylated' (imwaħħal ma' kimika magħrufa bħala polyethylene glycol).
English: PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Maltese: PegIntron, bi jew mingħajr ribavirin, tqabbel ma' interferon alfa-2b f'ħames studji li b'kollox involvew aktar minn 6,000 adult b'epatite C li ma kinux ġew ikkurati qabel, inkluż 328 pazjent b'ċirrożi u 507 pazjenti li kienu nfettati wkoll bl-HIV.
English: PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
Maltese: PegIntron huwa mediċina li fih is-sustanza attiva peginterferon alfa-2b.
English: The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal PegIntron fil25 ta' Mejju 2000.
English: In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Maltese: Fl-adulti (minn 18-il sena 'l fuq), PegIntron jista' jintuża f'pazjenti li ma jkunux ġew ittrattati qabel jew li t-trattament preċedenti tagħhom ma jkunx irnexxa.
English: The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Maltese: Il-kombinazzjoni ta' PegIntron ma' ribavirin ġiet studjata wkoll fi studju wieħed li kien jinvolvi 1,354 pazjent li l-kura preċedenti tagħhom ma kinitx irnexxiet u fi studju wieħed li kien jinvolvi 107 tfal u adoloxxenti ta' bejn tlieta u 17-il sena li ma kinux ġew ikkurati qabel.
English: The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'PegIntron, peginterferon alfa-2b, tagħmel parti mill-grupp magħruf bħala ‘interferons'.
English: What is PegIntron?
Maltese: X'inhu PegIntron?
English: Why has PegIntron been approved?
Maltese: Għaliex ġie approvat PegIntron?
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Maltese: Żewġ studji ewlenin li jinvolvu 1,503 pazjent adult bl-epatite Ċ tat-tip 1 u marda tal-fwied ikkumpensata investigaw l-effett ta' PegIntron f'terapija mħallta trippla ma' ribavirin u boceprevir meta mqabbla ma' PegIntron u ribavirin waħedhom.
English: The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li PegIntron għandu iktar benefiċċji milli riskji u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Dual therapy with ribavirin is also used in previously untreated children and adolescents (aged between three and 17 years) as long as their liver is still working normally.
Maltese: Terapija doppja ma' ribavirin tintuża wkoll fi tfal u adoloxxenti (ta' bejn 3 u 17-il sena) li jkunu ġew ittrattati qabel, dejjem jekk il-fwied tagħhom ikun għadu jaħdem normali.
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Maltese: F'adulti oħrajn bil-vajrus tal-epatite Ċ fiddemm tagħhom, inklużi pazjenti infettati wkoll bil-vajrus tal-immunodefiċjenza umana (HIV), PegIntron jingħata jew ma' ribavirin (terapija doppja) jew waħdu jekk ma jistgħux jieħdu ribavirin.
English: PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Maltese: PegIntron jista' jingħata f'terapija mħallta trippla ma' ribavirin u boceprevir lil adulti bl-epatite Ċ tat-tip 1 li l-fwied tagħhom ikun ġarrab ħsara iżda li jkun għadu jaħdem normali (mard tal-fwied ikkumpensat).
English: In adults, PegIntron was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to PegIntron alone and around a half responding to the combination of PegIntron and ribavirin.
Maltese: Fl-adulti, PegIntron kien iktar effikaċi minn interferon alfa-2b, f'pazjenti li ma kinux ġew ikkurati qabel, b'madwar kwart tal-pazjenti jwieġbu għal PegIntron waħdu u madwar nofs iwieġbu għall kombinazzjoni ta' PegIntron u ribavirin.
English: How has PegIntron been studied?
Maltese: Kif ġie studjat PegIntron?
English: What is the risk associated with PegIntron?
Maltese: X'inhu r-riskju assoċjat ma' PegIntron?
English: The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Maltese: Il-kombinazzjoni ta' PegIntron u ribavirin kienet iktar effikaċi f'pazjenti b'ċirrożi u f'pazjenti infettati bl-HIV.
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Maltese: Hemm ukoll żieda sinifikanti fir-rati ta' fejqan f'pazjenti b'epatite Ċ tat-tip 1 dejjiema meta jingħataw it-terapija tripla ta' PegIntron flimkien ma' ribavirin u boceprevir.
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
Maltese: Fl-istudji dwar it-terapija trippla f'pazjenti bl-epatite Ċ tat-tip 1 u mard tal-fwied ikkumpensat, intwera li PegIntron f'terapija mħallta ma' ribavirin u boceprevir huwa aktar effettiv mit-terapija mħallta doppja ta' PegIntron u ribavirin waħedhom.
English: The Committee noted that the dual combination with ribavirin was shown to be effective against longterm hepatitis C virus infection in adults and children.
Maltese: Il-Kumitat osserva li t-terapija mħallta doppja ma' ribavirin uriet li hija effettiva kontra l-infezzjoni dejjiema bil-vajrus tal-epatite Ċ fl-adulti u t-tfal.
English: PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Maltese: PegIntron ma għandux jintuża f'pazjenti b'kundizzjoni medika severa, bi problemi severi tal-fwied, b'mard tat-tirojde sakemm dan ma jkunx ikkontrollat, bl-epilessija jew bi problemi oħrajn tas-sistema nervuża ċentrali.
English: Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
Maltese: Minħabba li PegIntron huwa relatat mal-effetti sekondaji bħal depressjoni, il-pazjenti għandhom jiġu mmonitorjati mill-qrib matul il-kura.
English: In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Maltese: Fi tfal u adoloxxenti li jkunu qiegħdin jirċievu PegIntron ma' ribavirin, l-effetti sekondarji kienu simili għal dawk tal-adulti, għalkemm it-tkabbir imnaqqas deher ukoll f'aktar minn pazjent wieħed minn kull 10.
English: For a full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: PegIntron is also linked to weight loss and reduced growth in children and adolescents.
Maltese: PegIntron huwa relatat ukoll ma' telf fil-piż u ma' tnaqqis fittkabbir fi tfal u adoloxxenti.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Tamiflu a Direct Healthcare Professional Communication (DHPC) letter, the text of which is appended to the CHMP assessment report.
Maltese: L-Istati Membri għandhom jiżguraw li d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) jipprovdi lit-tobba kollha li huma mistennija jippreskrivu jew jużaw Tamiflu b'ittra ta' Komunikazzjoni Diretta għall-Professjonisti fil-kura tas-saħħa (DHPC), li it-test tagħha huwa mehmuż mar-rapport ta' valutazzjoni tas-CHMP.
English: The Member States shall agree with the MAH the communication plan for the DHPC letter.
Maltese: L-Istati Membri għandhom jaqblu mad-detentur talawtorizzazzjoni għat-tqegħid fis-suq (MAH) dwar pjan ta' komunikazzjoni għall-ittra DHPC.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Maltese: ANNESS KOndizzjonijiet jew restrizzjonijiet rigward l-użu mingħajr periklu u effettiv tal-prodott mediċinali li għandhom jiġu implimentati mill-istati membri
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/eu3151551
English: Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Maltese: ema.europa.eu/medicines/human/EPAR/Takhzyro.
English: Takhzyro contains the active substance lanadelumab.
Maltese: Takhzyro fih is-sustanza attiva lanadelumab.
English: Other information about Takhzyro
Maltese: Informazzjoni oħra dwar Takhzyro
English: Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 October 2015.
Maltese: Anġjoedema ereditarja hija rari, u Takhzyro ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fid-9 ta' Ottubru 2015.
English: Overall, the safety profile was considered acceptable.
Maltese: B'mod ġenerali, il-profil tas-sigurtà tqies aċċettabbli.
English: The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Maltese: Id-doża tal-bidu rakkomandata ta' Takhzyro hija 300 mg kull ġimagħtejn.
English: This compared with 2 attacks per month for patients on placebo (a dummy treatment).
Maltese: Dan tqabbel ma' 2 attakki fixxahar għal pazjenti fuq plaċebo (kura finta).
English: The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin.
Maltese: Is-sustanza attiva f'Takhzyro, il-lanadelumab, taħdem billi teħel ma' u timblokka enzima fid-demm imsejħa “kallikreina”, li għandha diversi funzjonijiet, inkluż li żżid il-livelli ta' bradikinin.
English: What are the risks associated with Takhzyro?
Maltese: X'inhuma r-riskji assoċjati ma' Takhzyro?
English: Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 12 years and over.
Maltese: Takhzyro huwa mediċina li tintuża biex tipprevjeni attakki ta' anġjoedema ereditajra f'pazjenti li għandhom 12-il sena u aktar.
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.
Maltese: Pazjenti b'anġjoedema ereditarja għandhom livelli għoljin ta' sustanza msejħa “bradikinin”, li tikkawża lill-vażijiet biex jintefħu u jnixxu fluwidu fit-tessut tal-madwar li jwassal għal attakki ta' nefħa bħalma jiġri fl-anġjoedema.
English: How is Takhzyro used?
Maltese: Takhzyro?
English: Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.
Maltese: Takhzyro nstab li kien effettiv fit-tnaqqis tal-għadd ta' attakki ta' anġjoedema fi studju ewlieni fuq 126 adult u tifel u tifla ‘l fuq minn 12-il sena b'anġjoedema ereditarja.
English: Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks.
Maltese: Il-pazjenti esperjenzaw bħala medja 0.3 attakki fix-xahar meta ngħataw injezzjonijiet ta' Takhzyro kull ġimagħtejn u 0.5 attakki meta ngħataw injezzjonijiet kull erba' ġimgħat.
English: As for all medicines, data on the use of Takhzyro are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Takhzyro hija ssorveljata kontinwament.
English: The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Takhzyro (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni inkluż eritema (ħmura), tbenġil u wġigħ.
English: By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.
Maltese: Billi timblokka l-azzjonijiet ta' kallikreina, il-lanadelumab tgħin tipprevjeni n-nefħa u sintomi relatati tal-anġjoedema.
English: Why is Takhzyro authorised in the EU?
Maltese: Għaliex Takhzyro huwa awtorizzat fl-UE?
English: Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Takhzyro huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Takhzyro is given as an injection under the skin, preferably in the abdomen (belly), thighs or upper arms.
Maltese: Takhzyro jingħata bħala injezzjoni taħt il-ġilda, preferibbilment fl-addome (iż-żaqq), fil-koxox jew filparti ta' fuq tad-dirgħajn.
English: For the full list of side effects and restrictions with Takhzyro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Takhzyro, ara l-fuljett ta' tagħrif.
English: Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.
Maltese: Takhzyro jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda taħt superviżjoni ta' tabib esperjenzat fil-ġestjoni ta' anġjoedema ereditarja.
English: n=98 n=48 n=50
Maltese: n = 98 n = 48
English: NN:
Maltese: CI:
English: Progressive multifocal leukoencephalopathy (PML)
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - Progressive multifocal leukoencephalopathy)
English: Rituzena contains the active substance “rituximab”.
Maltese: Rituzena fih is-sustanza attiva “rituximab”.
English: Summary of the safety profile (rheumatoid arthritis)
Maltese: Sommarju tal-profil ta' sigurtà (artrite rewmatika)
English: <2D barcode carrying the unique identifier included.>
Maltese: Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: severe cardiac disoders4 and 6
Maltese: disturbi kardijaċi severi 4 u 6
English: Rituzena is a biosimilar medicinal product.
Maltese: Rituzena huwa prodott mediċinali bijoloġiku simili.
English: Do not take Rituzena if:
Maltese: Tiħux Rituzena jekk:
English: Rituzena is indicated in adults for the following indications:
Maltese: Rituzena huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
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: Table 8 Complete remission at 6-months by disease status Cyclophosphamide Difference (CI 95%)
Maltese: Tabella 8 Remissjoni kompluta wara 6 xhur skont l-istat tal-marda Cyclophosphamide Differenza (CI 95%)
English: Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Maltese: Eċċipjenti: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, ilma għall-injezzjonijiet.
English: • The active ingredient in Rituzena is called rituximab.
Maltese: • Is-sustanza attiva fi Rituzena hija msejħa rituximab.
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 5a and Table 5b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 6) were analysed for efficacy.
Maltese: Total ta' 810 pazjent (403 R-FC, 407 FC) għall-istudju primarju (Tabella 5a u Tabella 5b) u 552 pazjent (276 R-FC, 276 FC) għall-istudju dwar CLL li reġgħet tfaċċat/refrattarja (Tabella 6) kienu analizzati
English: A total of 23/99 (23%) rituximab-treated patients in the trial tested positive for HACA by 18 months.
Maltese: Total ta' 23/99 (23%) pazjent ikkurat b'rituximab fil-prova kienu pożittivi għal HACA wara 18-il xahar.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, antikorpi monoklonali, kodiċi ATC:
English: Of 356 patients evaluated for HACA, 1.1 % (4 patients) were positive.
Maltese: Mit-356 pazjent evalwat għall-HACA, 1.1% (4 pazjenti) kienu pożittivi.
English: Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with rituximab compared to <1% on observation.
Maltese: Avvenimenti kardijaċi kienu rrappurtati bħala avvenimenti avversi severi (inkluż fibrillazzjoni atrijali, infart mijokardijaku, insuffiċjenza ventrikolari tax-xellug, iskemija mijokardijaka) f'3% tal-pazjenti kkurati b'rituximab meta mqabbel ma' < 1% fuq osservazzjoni.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and very rare (<1/10,000).
Maltese: (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000
English: 20 Academy-ro 51 beon-gil
Maltese: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Repubblika tal-Korea
English: Summary of the safety profile (non-Hodgkin's lymphoma and chronic lymphocytic leukaemia)
Maltese: Sommarju tal-profil tas-sigurtà (limfoma mhux ta' Hodgkin u lewkimja limfoċitika kronika)
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and
Maltese: Dan jinkludi artrite rewmatika u mard awtoimmuni off-label ieħor, inkluż Lupus Eritematosus Sistemika (SLE) u vaskulite.
English: The ORR was 36 % (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Maltese: ORR kienet ta' 36% (CI95% 21% - 51%; CR 3%, PR 33%) b'TTP medjan għal pazjenti li rrispondew ta' 9.6 xhur (firxa minn 4.5 sa 26.
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Maltese: R-CVP wassal għal benefiċcju sinifikanti fuq CVP għall-punt finaliprimarju, iż żmien sal-falliment tal-kura (27 xahar vs. 6.6 xhur, p < 0.0001, test log-rank).
English: In the 99 rituximab patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6-month primary endpoint.
Maltese: Fid-99 pazjent fuq rituximab, ir-rata globali ta' infezzjoni kienet ta' madwar 237 għal kull 100 sena ta' pazjent (CI ta' 95% 197-285) fil-punt finali primarju ta' 6 xhur.
English: Date of first authorisation: 13 July 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta 'Lulju, 2017
English: Very Rare Not known serious viral infection2
Maltese: Rari ħafna Mhux magħrufa infezzjoni serja ikkawżata minn virus2
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Maltese: Rituzena, flimkien ma' glukokortikojdi, huwa indikat għall-induzzjoni ta' remissjoni f'pazjenti adulti bi granulomatosi b'polianġite (ta' Wegener) (GPA - granulomatosis with polyangiitis) attiva u severa u polianġite mikroskopika (MPA - microscopic polyangiitis).
English: FC R‐FC
Maltese: R-FC
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6 % vs. 15.4 %).
Maltese: Kien hemm inċidenza ogħla ta' ADRs ta' grad 3/4 f'pazjenti b'bulky disease meta mqabbel ma' pazjenti mingħajr bulky disease (25.6% vs 15.
English: At 6 months, in the active-controlled, randomised, double-blind, multicentre, non-inferiority trial, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
Maltese: Wara 6 xhur, fil-prova kkontrollata b'attiv, randomised, double-blind, b'aktar minn ċentru wieħed, dwar nuqqas ta' inferjorità, fil-grupp ta' rituximab, 27%, 58% u 51% tal-pazjenti b'livelli normali ta' immunoglobulina fil-linja bażi, kellhom livelli ta' IgA, IgG u IgM baxxi, rispettivament meta mqabbla ma' 25%, 50% u 46% fil-grupp ta' cyclophosphamide.