FrancophonIA/ELRC3.0 huggingface dataset:
English: The physician in charge of the diabetic care of the patient should be informed when {direct acting antiviral / DAA} therapy is initiated.
Maltese: It-tabib responsabbli għall-kura dijabetika tal-pazjent għandu jiġi infurmat meta tinbeda t-terapija {b'mediċina antivirali li taġixxi direttament / DAA}.
English: Infusion bag - Baxter minibag NaCl 0.9%
Maltese: Borża tal-infużjoni - Baxter minibag NaCl 0.9%
English: Centre de Biotechnologie 8 rue de l'Industrie 68330 Huningue France
Maltese: Centre de Biotechnologie 8 rue de l'Industrie 68330
English: 90429 Nuremberg Germany
Maltese: 90429 Nürnberg Il-Ġermanja
English: Тел.
Maltese: Tel.
English: Elderly ( 65 years)
Maltese: Anzjani ( 65 sena)
English: Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.15.1 mg/l.
Maltese: L-ogħla konċentrazzjonijiet fisserum wara infużjonijiet intravenużi ta' 20 mg fuq 30 minuta hi ta' 7.15.1 mg/l.
English: The terminal half-life was 7.23.2 days.
Maltese: Il-halflife terminali kienet ta' 7.23.2 jiem.
English: Immunogenicity
Maltese: Immonoġeniċità
English: Listing of adverse reactions from post-marketing spontaneous reports
Maltese: Lista ta' reazzjonijiet avversi minn rapporti spontanji wara t-tqegħid fis-suq
English: Cumulative doses ranged from 20 mg up to 60 mg.
Maltese: Dożi kumulattivi varjaw minn 20 mg sa 60 mg.
English: What Simulect contains - The active substance is basiliximab.
Maltese: X'fih Simulect - Is-sustanza attiva hi basiliximab.
English: Pregnancy and lactation (see section 4.6).
Maltese: Tqala u treddigħ (ara sezzjoni 4.6).
English: Date of first authorisation: 09/10/1998 Date of latest renewal: 09/10/2008
Maltese: Data tal-aħħar tiġdid: 09/10/2008
English: Children and adolescents (1-17 years)
Maltese: Tfal u adolexxenti (1sa 17-il sena)
English: The rates of BPAR were 9.4% in the basiliximab group and 17.4% in the placebo group (HR: 0.50, 90% CI: [0.25; 0.99]).
Maltese: Ir-rati tal-BPAR kienu 9.4% fost ilgrupp mogħti basiliximab u 17.4% fost il-grupp mogħti plaċebo (HR: 0.50, 90% CI: [0.25; 0.99]).
English: - The other ingredients are potassium dihydrogen phosphate; disodium phosphate, anhydrous;
Maltese: - Is-sustanzi l-oħra huma: potassium dihydrogen phosphate; disodium phosphate, anhydrous;
English: Other medicines and Simulect
Maltese: Mediċini oħra u Simulect
English: It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
Maltese: Fih ukoll potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
English: • Risk Management Plan (RMP) Not applicable.
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP) Mhux applikabbli.
English: Simulect should be administered under qualified medical supervision.
Maltese: Simulect għandu jingħata taħt superviżjoni ta' speċjalisti mediċi kwalifikati.
English: When borderline rejections were included, the rates were 20.8% and 19.6% respectively (HR: 1.01, 90% CI: [0.59; 1.72]).
Maltese: 8% u 19.6% rispettivament (HR: 1.01, 90% CI: [0.59; 1.72]).
English: Simulect belongs to a group of medicines called immunosuppressants.
Maltese: Simulect jifforma parti minn grupp ta' mediċini li jissejħu immunosoppressiva.
English: set, Abbott - Infusion set, Codan - Infusomat, Braun - Infusionsgerät R 87 plus, Ohmeda - Lifecare 5000Plumset Microdrip, Abbott - Vented basic set, Baxter - Flashball device, Baxter - Vented primary administration set, Imed
Maltese: Plumset Microdrip, Abbott - Vented basic set, Baxter - Flashball device, Baxter - Vented primary administration set, Imed
English: When borderline rejections were included in the primary efficacy endpoint, the rates were 26.0% and 23.9% respectively, with no statistically significant difference between the basiliximaband placebo-treated groups (HR: 1.04, 90% CI: [0.64; 1.68]).
Maltese: Meta kienu inklużi r-riġetti fil-linja ta' demarkazzjoni fejn jidħol l-endpoint primarju dwar l-effikaċja, ir-rati kienu 26.0% u 23.9% rispettivament, bla differenza sinifikanti statistikament bejn gruppi kkurati b'basiliximab u dawk bi plaċebo (HR: 1.04, 90% CI: [0.64; 1.68]).
English: Elimination half-life was not influenced by age, gender, or race.
Maltese: Il-half-life tal-eliminazzjoni ma ġietx influwenzata mill-età, sess jew razza.
English: Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Maltese: Minħabba li basiliximab huwa immunoglobina, mhux mistenni li jkun hemm ebda interazzjoni metabolika bejn mediċina u oħra.
English: Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2).
Maltese: Simulect indikat għall-profilassi ta' riġett akut ta' organu f'trapjant alloġeniku renali de novo, f'pazjenti kemm adulti kif ukoll pedjatriċi (1-17-il sena) (ara sezzjoni 4.2).
English: No mutagenic potential was observed in vitro.
Maltese: In vitro, ma ġie osservat l-ebda potenzjal mutaġeniku.
English: The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
Maltese: Il-farmakokinetiċi ta' basiliximab ġew studjati f'39 pazjent pedjatriku bi trapjant renali de novo.
English: Of the 202 patients, 104 were randomised to basiliximab and 98 to placebo.
Maltese: Mill-202 pazjenti, 104 ntgħażlu b'mod randomizzat biex jingħataw basiliximab u 98 biex jingħataw plaċebo.
English: Results from two pivotal 12-month multicentre studies (722 patients in total) comparing basiliximab with placebo show that basiliximab, used concomitantly with ciclosporin for microemulsion and corticosteroids, significantly reduces the incidence of acute rejection episodes both within 6 (31% vs. 45%, p<0.001) and 12 (33% vs. 48%, p<0.001) months after transplantation.
Maltese: Riżultati minn żewġ studji multiċentri pivotali ta' 12-il xahar (total ta' 722 pazjent) li qabblu basiliximab ma' plaċebo juru li basiliximab, meta jingħata ma' ciclosporin għal mikroemulsjoni u kortikosterojdi, inaqqas b'mod sinifikanti l-inċidenza ta' episodji ta' riġett akut kemm fi żmien 6 xhur (31% vs. 45%, p<0.001) kif ukoll fi żmien 12 (33% vs. 48%, p<0.001)-il xahar wara t-trapjant.
English: Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
Maltese: Minn 339 pazjent ta' trapjanti renali li ngħataw basiliximab u li ġew eżaminati għall-preżenza ta' antikorpi anti-idiotype, 4 (1.2%) żviluppaw rispons għall-antikorpi anti-idiotype.
English: The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies.
Maltese: L-effikaċja ta' basiliximab biex jilqa' kontra riġett ta' organu fi trapjant renali de novo intweriet fi studji double blind kontrollati bil-plaċebo.
English: In adolescents (age 12-16 years, n=14), the steady-state distribution volume was 7.85.1 l, half-life was 9.13.9 days and clearance was 3119 ml/h.
Maltese: Fl-adolexxenti (età ta' 12-16-il sena, n=14), il-volum ta' distribuzzjoni fi stat fiss kien ta' 7.85.1 l, il-half-life kienet ta' 9.13.9 jiem u t-tneħħija kienet ta' 3119 ml/siegħa.
English: The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly.
Maltese: Il-frekwenza kienet ta' 2/138 f'pazjenti li ma kinux esposti għal muromonab-CD3 (OKT3) u ta' 4/34 f'pazjenti li kienu ngħataw muromonab-CD3 f'daqqa.
English: Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
Maltese: Id-doża standard totali hija ta' 40 mg, mogħtija f'żewġ dożi ta' 20 mg kull waħda.
English: Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Maltese: Tagħrif fuq is-sigurtà ta' pazjenti pedjatriċi nkiseb minn studju farmakokinetiku u farmakodinamiku open label wieħed fuq pazjenti li kellhom trapjant renali (41 pazjent).
English: Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).
Maltese: Basiliximab kien eżaminat f'erba' studji double blind, randomised, kontrollati bil-plaċebo, fuq pazjenti li kellhom trapjant renali bħala aġent ta' induzzjoni flimkien mal-korsijiet immunosoppressivi li ġejjin: ciclosporin għal mikroemulsjoni u kortikosterojdi f'żewġ studji (346 u 380 pazjent), ciclosporin għal mikroemulsjoni, azathioprine u kortikosterojdi fi studju wieħed (340 pazjent) u ciclosporin għal mikroemulsjoni, mycophenolate mofetil u kortikosterojdi fi studju ieħor (123 pazjent).
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Aħżen fi friġġ (2C - 8C).
English: Other malignancies were reported among 1.0% (7/701) of patients in the basiliximab group compared with 1.2% (7/595) of placebo patients.
Maltese: Tumuri oħrajn dehru f'1.0% (7/701) tal-pazjenti fil-grupp basiliximab, kontra 1.2% (7/595) tal-pazjenti bil-plaċebo.
English: In a clinical trial with 172 patients receiving basiliximab, the incidence of human antimurine antibody (HAMA) in renal transplantation patients treated with basiliximab was 2/138 in patients not exposed to muromonab-CD3 and 4/34 in patients who received muromonab-CD3 concomitantly.
Maltese: Fi prova klinika b'172 pazjent li ngħataw basiliximab, l-inċidenza ta' antikorp antimurin uman (HAMA) f'pazjenti ta' trapjanti tal-kliewi li ngħataw basiliximab kienet ta' 2/138 f'pazjenti li ma kinux esponuti għallmuromonab-CD3, kontra 4/34 f'pazjenti li ngħataw muromonab-CD3 fl-istess ħin.
English: In infants and children (age 1-11 years, n=25), the steady-state distribution volume was 4.82.1 l, half-life was 9.54.5 days and clearance was 176 ml/h.
Maltese: Fittfal żgħar u t-tfal (età ta' 1-11-il sena, n=25), il-volum ta' distribuzzjoni fi stat fiss kien ta' 4.82.1 l, il-half-life kienet ta' 9.54.5 jiem, u l-tneħħija kienet ta' 176 ml/siegħa.
English: In a pooled analysis of two fiveyear extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% (21/295) and placebo 7% (21/291) (see section 4.4).
Maltese: Analiżi kollettiva ta' żewġ studji ta' ħames snin li ġew estiżi, linċidenza ta' LPDs u tumur kienet indaqs f'basiliximab 7% (21/295) u fil-plaċebo 7% (21/291) (ara sezzjoni 4.4).
English: There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions.
Maltese: Aktar evidenza qed turi li sottogrupp ta' pazjenti għandhom riskju akbar li jiżviluppaw reazzjonijiet ta' sensittività eċċessiva.
English: Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability.
Maltese: Rispons għall-antikorpi antimurini umani (HAMA) kienu rrappurtati waqt prova klinika b' 172 pazjent li ngħataw basiliximab, mingħajr ma kien imbassar valur għat-tollerabilità klinika.
English: The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being infections (basiliximab = 1.3%, placebo = 1.4%).
Maltese: L-inċidenza u l-kawżi tal-imwiet wara terapija bi tnejn jew bi tlieta kienu simili fil-gruppi basiliximab (2.9%) u f'dawk plaċebo (2.6%), bil-kawża l-aktar komuni tal-imwiet fiż-żewġ gruppi ta' kura tkun linfezzjonijiet (basiliximab = 1.3%, plaċebo = 1.4%).
English: Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02.
Maltese: Impedituri ta' interlukin, Kodiċi ATC:
English: 1 vial with 10 mg powder 1 ampoule with 5 ml solvent
Maltese: Ampulla waħda ta' 5 ml solvent
English: Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome (see section 4.4).
Maltese: Reazzjonijiet ta' sensittività eċċessiva/anafilaktojd bħal raxx, urtikarja, ħakk, għatis, tħarħir, bronkospażmi, qtugħ ta' nifs, edema fil-pulmun, insuffiċjenza kardijaka, pressjoni baxxa, takikardija, insuffiċjenza respiratorja, sindrome ta' tnixxija tal-kapillari (ara sezzjoni 4.4).
English: Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6).
Maltese: L-istabilità kimika u fiżika tas-soluzzjoni imħallta intweriet għal 24 siegħa f'2C - 8C jew għal 4 sigħat f'temperatura ambjentali (ara sezzjoni 6.6).
English: Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load.
Maltese: Korsijiet immunosoppressivi li jinvolvu taħlit ta' medikazzjonijiet jżidu s-suxxettibilità għallinfezzjonijiet, inklużi infezzjonijiet opportunistiċi, infezzjonijiet fatali u sepsi; ir-riskju żdied mattagħbija immunosoppressiva totali.
English: Powder
Maltese: Tilqim
English: Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes.
Maltese: Simulect rikostitwit jista' jingħata bħala injezzjoni f'daqqa (bolus) fil-vina jew bħala infużjoni intravenuża fuq medda ta' 20-30 minuta.
English: Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection.
Maltese: Basiliximab speċifikament jintrabat b'affinità qawwija (valur-KD 0.1 nM) ma' l-antiġen CD25 fuq limfoċiti-T li jkunu attivi, u jikxef ir-riċettur interlukin-2 (IL-2R) li għandu affinità għolja, biex b'hekk iwaqqaf milli jingħaqad l-interlukin-2, sinjal kritiku li jwassal għall-proliferazzjoni taċ-ċelluli-T fir-rispons ċellulari immuni involut fir-riġett tal-allograft.
English: Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression.
Maltese: Simulect għandu jintuża ma' ciclosporin għall-immunosupressjoni bbażata fuq mikroemulsjoni jew kortikosterojdi.
English: Overall, lymphoma/lymphoproliferative disease occurred in 0.1% (1/701) of patients in the basiliximab group compared with 0.3% (2/595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.
Maltese: Limfoma/mard limfoproliferattiv seħħew f'0.1% (1/701) tal-pazjenti fil-grupp basiliximab, imqabbla ma' 0.3% (2/595) fost il-pazjenti li kienu qed jirċievu plaċebo, kemm fit-terapija kombinata bi tnejn kif ukoll bi tlieta.
English: Basiliximab is a murine/human chimeric monoclonal antibody (IgG1) that is directed against the interleukin-2 receptor -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge.
Maltese: Basiliximab huwa antikorp monoklonali kimeriku tal-ġurdien/uman (IgG1) li huwa immirat kontra lkatina- tar-riċettur interlukin-2 (antiġen CD25), li hija espressa fuq is-superfiċje tal-limfoċiti-T bħala rispons għall-kuntatt ma' l-antiġen.
English: The overall incidence of treatment-related adverse events among all patients in the individual studies was not significantly different between the basiliximab (7.1% - 40%) and the placebo (7.6% - 39%) treatment groups.
Maltese: L-inċidenza globali tal-effetti avversi relatati malkura fost il-pazjenti kollha fl-istudji individwali ma kienitx differenti b'mod sinifikanti bejn il-gruppi ta' kura b'basiliximab (7.1% - 40%) u tal-plaċebo (7.6% - 39%).
English: The overall incidence of infections was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious infections was 26.1% and 24.8%, respectively.
Maltese: L-inċidenza globali ta' infezzjonijiet kienet 75.9% fil-grupp b'basiliximab u 75.6% fil-grupp bil-plaċebo u l-inċidenza ta' infezzjonijiet serji kienet ta' 26.
English: Overall the adverse event profile was consistent with general clinical experience in the paediatric renal transplantation population and with the profile in the controlled adult transplantation studies.
Maltese: Il-profil globali tal-effetti avversi kien konsistenti ma' l-esperjenza ġenerali klinika tal-popolazzjoni pedjatrika tat-trapjant tal-kliewi u ma' dak li ntwera fi studji kkontrollati tat-trapjanti fl-adulti.
English: Results from two multicentre double-blind studies comparing basiliximab with placebo (463 patients in total) show that basiliximab significantly reduces the incidence of acute rejection episodes within 6 months after transplantation when used concomitantly with ciclosporin for microemulsion, corticosteroids, and either azathioprine (21% vs. 35%) or mycophenolate mofetil (15% vs. 27%).
Maltese: Ir-riżultati minn żewġ studji multiċentri double blind li qabblu basiliximab ma' plaċebo (total ta' 463 pazjent) juru li basiliximab inaqqas b'mod sinifikanti l-inċidenza ta' episodji ta' riġett akut sa 6 xhur wara t-trapjant, meta dan jiġi wżat flimkien ma' ciclosporin għal mikroemulsjoni, kortikosterojdi, u jew azathioprine (21% vs.
English: The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.
Maltese: L-effetti l-aktar komuni li dehru (> 20%) wara terapija bi tnejn jew bi tlieta fiż-żewġ gruppi kkurati (basiliximab vs. plaċebo) kienu stitikezza, infezzjonijiet fit-tratt urinarju, uġigħ, dardir, edima periferika, pressjoni għolja, anemija, uġigħ ta' ras, iperkalimja, iperkolesterolimja, komplikazzjoni talġerħa kirurġika, żieda fil-piż, żieda fil-livell tal-krejatinina fid-demm, ipofosfatimja, dijarea, u infezzjoni fl-apparat respiratorju fin-naħa ta' fuq.
English: A 12-month, randomised, placebo-controlled, double-blind, multicentre study investigated basiliximab in combination with ciclosporin for microemulsion, mycophenolate mofetil and steroids in paediatric renal allograft recipients.
Maltese: Studju randomizzat, ikkontrollat bi plaċebo, double-blind, multiċentriku li dam għaddej 12-il xahar stħarreġ l-għoti flimkien ta' basiliximab ma' ciclosporin għall-mikroemulsjoni, mycophenolate mofetil u sterojdi f'pazjenti pedjatriċi b'allograft renali.
English: Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus [CMV], BK virus).
Maltese: Pazjenti li kellhom trapjant li qed jirċievu kura immunosoppressiva b'korsijiet flimkien ma' basiliximab jew mingħajru għandhom riskju akbar li jiżviluppaw mard limfoproliferattiv (LPDs) (bħal-limfoma) u infezzjonijiet opportunistiċi (bħal ċitomegalovirus [CMV], BK virus).
English: In several small clinical trials in heart transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) and palpitations (1.4%) have been reported more frequently with Simulect than with other induction agents.
Maltese: F'diversi provi kliniċi żgħar f'riċevituri ta' trapjant tal-qalb, avvenimenti avversi kardijaċi serji bħal attakk tal-qalb (2.2%), palpitazzjoni tal-atriju (1.9%) u palpitazzjonijiet (1.4%) kienu rrappurtati aktar ta' spiss b'Simulect milli b'sustanzi oħra ta' induzzjoni.
English: The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs.  35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.
Maltese: L-aktar effetti komuni (> 20%) li dehru wara terapija bi tnejn fiż-żewġ gruppi (piż ta' < 35 kg vs.  35 kg) kienu infezzjonijiet fit-tratt urinarju, ipertrikożi, rajnajtis, deni, pressjoni għolja, infezzjoni flapparat respiratorju fin-naħa ta' fuq, infezzjoni b'vajruses, sepsis u stitikezza.
English: No toxicity was observed when rhesus monkeys received intravenous doses of either up to 5 mg/kg basiliximab twice weekly for 4 weeks followed by an 8-week withdrawal period or 24 mg/kg basiliximab weekly for 39 weeks followed by a 13-week withdrawal period.
Maltese: Ma ġiet osservata l-ebda tossiċità meta xadini rhesus ingħataw dożi intravenużi li waslu sa 5 mg/kg ta' basiliximab darbtejn fil-ġimgħa għal 4 ġimgħat segwita b'perijodu ta' twaqqif ta' 8-ġimgħat jew sa 24 mg/kg ta' basiliximab darba fil-ġimgħa għal 39 ġimgħa segwit b'13-il ġimgħa perijodu ta' twaqqif.
English: Water for injections
Maltese: Neoplażmi u infezzjonijiet
English: The solvent ampoule contains 5 ml water for injections.
Maltese: L-ampulla tas-solvent fiha 5 ml ilma għall-injezzjonijiet.
English: Older patients (aged 65 years and over)
Maltese: Pazjenti akbar fl-età (li għandhom 65 sena u aktar)
English: Each vial contains 10 mg basiliximab*.
Maltese: Kull kunjett fih 10 mg basiliximab*.
English: Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.
Maltese: F'każ bħal dan jista' jkun li diġà ngħatajt Simulect.
English: In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with antibody therapy (OKT 3 or antithymocyte globulin/antilymphocyte globulin [ATG/ALG]), with no increase in adverse events or infections in the basiliximab group as compared to placebo.
Maltese: III fl-ewwel 3 xhur ta' wara t-trapjant, 14% tal-pazjenti fil-grupp ta' basiliximab u 27% fil-grupp tal-plaċebo, kellhom episodju ta' riġett akut li ġie ikkurat b'terapija talantikorpi (OKT3 jew antithymocyte globulin/antilymphocyte globulin (ATG/ALG)), mingħajr ma żdiedu r-reazzjonijiet avversi jew l-infezzjonijiet fil-grupp ta' basiliximab meta mqabbel mal-grupp tal-plaċebo.
English: The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo (see section 4.8).
Maltese: L-użu ta' basiliximab f'kors bi tlett sustanzi li jinkludi azathioprine jew mycophenolate mofetil, l-effetti avversi ma żdiedux u l-anqas l-infezzjonijiet filgrupp ta' Simulect meta mqabbla mal-grupp tal-plaċebo (ara sezzjoni 4.8).
English: Complete and consistent blocking of the interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 g/ml (usually up to 4-6 weeks after administration).
Maltese: Limblokkar komplet u konsistenti tar-riċettur interlukin-2 jinżamm kemm-il darba l-livell ta' basiliximab fis-serum jibqa' ogħla minn 0.2 g/ml (normalment minn 4 sa 6 ġimgħat wara li jingħata).
English: Simulect 20 mg powder for solution for injection/infusion basiliximab
Maltese: Simulect 20 mg trab għal soluzzjoni għall-injezzjoni/infużjoni basiliximab
English: Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Maltese: Basiliximab intuża flimkien ma' ciclosporin għal mikroemulsjoni u sterojdi fi studju mhux kontrollat f'41 reċipjent ta' trapjanti tal-kliewi de novo pedjatriċi.