qanastek/EMEA-V3 huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal Simulect lil Novartis Europharm Limited fid- 9 ta ’ Ottubru 1998.
The marketing authorisation was renewed on 9 October 2003 and on 9 October 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 9 ta ’ Ottubru 2003 u fid- 9 ta ’ Ottubru 2008.
The full EPAR for Simulect can be found here.
L- EPAR sħiħ għal Simulect jiġi kkonsultat hawn.
Simulect 20 mg powder and solvent for solution for injection or infusion
Simulect 20 mg trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni
Each vial contains 20 mg basiliximab*.
Kull kunjett fih 20 mg basiliximab *.
One ml of the reconstituted solution contains 4 mg basiliximab.
Millilitru wieħed tas- soluzzjoni rikostitwita fih 4 mg basiliximab.
* recombinant murine/ human chimeric monoclonal antibody directed against the interleukin-2 receptor α -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.
* antikorp rikombinanti monoklonali kimeriku tal- ġurdien/ bniedem immirat kontra l- katina- α tar - riċettur ta ’ interleukin- 2 (antiġen CD25) magħmul minn linja ta’ ċelluli tal- majeloma ta ’ ġurdien permezz tat- teknoloġija ta ’ DNA rikombinat.
Powder and solvent for solution for injection or infusion
Trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni.
White powder
Trab abjad.
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).
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).
It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Għandu jintuża flimkien ma ’ ciclosporin għall- immunosupressjoni bbażata fuq mikroemulsjoni u kortikosterojdi, jew f’ pazjenti li għandhom anqas minn 80% ta ’ l- antikorpi reattivi għall- pannell, jew inkella f’ pazjenti fuq kors bi tlett sustanzi għall- manutenzjoni ta ’ l- immosuppressjoni, li jkun fiha ciclosporin għal mikroemulsjoni, kortikosterojdi u azathioprine jew mycophenolate mofetil.
Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Simulect għandu jinkiteb biss minn tobba li għandhom esperjenza b’ terapija immunosuppressiva li tingħata wara trapjant ta ’ organu.
Simulect should be administered under qualified medical supervision.
Simulect għandu jingħata taħt superviżjoni ta ’ speċjalisti mediċi kwalifikati.
Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect m’ għandux jingħata sakemm ma jkunx aċċertat b’ mod assolut li l- pazjent ser jirċievi trapjant u immunosoppressjoni f’ daqqa.
Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression.
Simulect għandu jintuża ma ’ ciclosporin għall- immunosupressjoni bbażata fuq mikroemulsjoni jew kortikosterojdi.
It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.
Jista ’ jintuża f’ kors bi tlett sustanzi għall- manutenzjoni ta ’ l- immosuppressjoni, li jkun fiha ciclosporin għal mikroemulsjoni, kortikosterojdi u azathioprine jew mycophenolate mofetil.
Posology Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
Pożoloġija Adulti Id- doża standard totali hija ta ’ 40 mg, mogħtija f’ żewġ dożi ta ’ 20 mg kull waħda.
The first 20 mg dose should be given within 2 hours prior to transplantation surgery.
L- ewwel doża ta ’ 20 mg għandha tingħata sagħtejn qabel il- kirurġija tat- trapjant.
The second 20 mg dose should be given 4 days after transplantation.
It- tieni doża ta ’ 20 mg għandha tingħata erbat ijiem wara t- trapjant.
The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
It- tieni doża m’ għandhiex tingħata f’ każ ta ’ reazzjoni qawwija u sensittività eċċessiva għal Simulect jew komplikazzjonijiet wara l- operazzjoni bħal meta jkun hemm telf tat- trapjant (ara sezzjoni 4. 4).
2 Children and adolescents (1– 17 years) In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
2 Tfal u adolexxenti (1sa 17- il sena) F’ pazjenti pedjatriċi li jiżnu anqas minn 35 kg, id- doża totali rakkomandata hija ta ’ 20 mg, mogħtija f’ żewġ dożi ta ’ 10 mg kull waħda.
In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i. e. a total dose of 40 mg, given in two doses of 20 mg each.
F’ pazjenti pedjatriċi li jiżnu 35 kg jew aktar, id- doża rakkomandata hija d- doża għall- adulti, jiġifieri doża totali ta ’ 40 mg, mogħtija f’ żewġ dożi ta ’ 20 mg kull waħda.
The first dose should be given within 2 hours prior to transplantation surgery.
L- ewwel doża għandha tingħata sa sagħtejn qabel il- kirurġija tat- trapjant.
The second dose should be given 4 days after transplantation.
It- tieni doża għandha tingħata erbat ijiem wara t- trapjant.
The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
It- tieni doża m’ għandhiex tingħata f’ każ ta ’ reazzjoni ta ’ sensittività eċċessiva għal Simulect jew komplikazzjonijiet wara l- operazzjoni bħal telf tat- trapjant (ara sezzjoni 4. 4).
Elderly (≥ 65 years) There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.
Anzjani (≥ 65 sena) Hemm informazzjoni limitata dwar l- użu ta ’ Simulect fl- anzjani, iżda m’ hemmx evidenza li pazjenti anzjani għandhom bżonn doża differenti minn pazjenti adulti iżgħar fl- età.
Method of administration Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20– 30 minutes.
Metodu ta ’ kif għandu jingħata Simulect rikostitwit jista ’ jingħata bħala injezzjoni f’ daqqa (bolus) fil- vina jew bħala infużjoni intravenuża fuq medda ta ’ 20– 30 minuta.
For information on reconstitution, see section 6.6.
Għal informazzjoni dwar ir- rikostituzzjoni, ara sezzjoni 6. 6.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
(ara sezzjoni 6. 1).
Pregnancy and lactation (see section 4.6).
Tqala u treddigħ (ara sezzjoni 4. 6).
Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.
Pazjenti li qed jingħataw Simulect għandhom jiġu kkurati f’ postijiet li jkunu mgħammra b’ riżorsi ta ’ laboratorju adattat u riżorsi mediċi ta ’ support, li jinkludu mediċini għall- kura ta ’ reazzjonijiet qawwija minħabba sensittività eċċessiva.
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.
Korsijiet immunosoppressivi li jinvolvu taħlit ta ’ medikazzjonijiet jżidu s- suxxettibilità għall - infezzjonijiet, inklużi infezzjonijiet opportunistiċi, infezzjonijiet fatali u sepsi; ir- riskju żdied mat - tagħbija immunosoppressiva totali.
Hypersensitivity Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy.
Sensittività eċċessiva Reazzjonijiet qawwija u akuti (f’ anqas minn 24 siegħa) minħabba sensittività eċċessiva ġew osservati kemm fil- bidu ta ’ l- użu ta ’ Simulect, kif ukoll meta dan reġa ’ ntuża għal kors ieħor ta ’ terapija.
These included anaphylactoid-type reactions such as urticaria, pruritus, sneezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema and respiratory failure.
Dawn jinkludu reazzjonijiet simili għal dawk anafilattiċi bħal urtikarja, ħakk, għatis, pressjoni baxxa, takikardja, qtugħ ta ’ nifs, bronkospażmi, ilma fil- pulmun u insuffiċjenza respiratorja.
There have been rare reports of such reactions in patients receiving Simulect (< 1/ 1,000 patients).
Kien hemm każijiet rari fejn pazjenti kellhom reazzjonijiet bħal dawn meta ngħataw Simulect (< 1/ 1, 000 pazjent).
If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered.
Jekk ikun hemm reazzjoni qawwija minħabba sensittività eċċessiva, it- terapija b’ Simulect għandha titwaqqaf b’ mod permanenti, u l- ebda doża oħra m’ għandha terġa ’ tingħata.
Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.
Għadha ssir kawtela meta pazjenti li qabel kienu ngħataw Simulect jerġgħu jiġu esposti mill- ġdid għal kors ta ’ terapija ieħor b’ dan il- prodott mediċinali.
There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions.
Aktar evidenza qed turi li sottogrupp ta ’ pazjenti għandhom riskju akbar li jiżviluppaw reazzjonijiet ta ’ sensittività eċċessiva.
These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.
Dawn huma pazjenti li, wara l- ewwel għoti ta ’ Simulect, l- immunosoppressjoni li kienet qed tingħata fl- istess ħin kellha titwaqqaf kmieni minħabba, per eżempju, li t- trapjant ma sarx jew minħabba li t- trapjant intilef minn kmieni.
Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients.
Reazzjonijiet ta ’ sensittività eċċessiva dehru meta Simulect reġa ’ ngħata għal trapjant li sar aktar tard f’ xi pazjenti.
In a pooled analysis of two
Pazjenti li kellhom trapjant li qed jirċievu kura immunosoppressiva b’ korsijiet flimkien ma ’ basiliximab jew mingħajru għandhom riskju akbar li jiżviluppaw mard limfoproliferattiv (LPDs)
3 five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without combination of basiliximab (see section 4.8).
F’ analiżi miġbura minn żewġ studji ta ’ ħames snin, ma dehru l- edba żiediet fl- inċidenza ta ’ tumuri u fl- LPDs bejn korsijiet b’ immunosoppressivi flimkien ma ’ basiliximab jew mingħajru (ara sezzjoni 4. 8).
Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
Minħabba li basiliximab huwa immunoglobina, mhux mistenni li jkun hemm ebda interazzjoni metabolika bejn mediċina u oħra.
In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other concomitant medications routinely administered in organ transplantation have been administered in clinical trials without any incremental adverse reactions.
Minbarra ciclosporin għal mikroemulsjoni, sterojdi, azathioprine u mycophenolate mofetil, medikamenti oħra li s- soltu jingħataw f’ każ ta ’ trapjant ta ’ organu, ġew mogħtija ma ’ Simulect waqt provi kliniċi mingħajr ma kien hemm xi reazzjonijiet avversi żejda.
These concomitant medications include systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications such as beta-blocking agents or calcium channel blockers, and diuretics.
Dawn il- medikamenti l- oħra li ngħataw miegħu jinkludu medikamenti kontra l- vajruses, kontra l- batterji u kontra l- moffa, analġeżiċi, mediċini kontra l- pressjoni għolja, bħal aġenti imblukkaturi- beta jew imblukkaturi tal- kanali ta ’ calcium, jew dijuretiċi.
Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability.
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.
The incidence was 2/ 138 in patients not exposed to muromonab-CD3 (OKT3) and 4/ 34 in patients who received muromonab-CD3 concomitantly.
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.
The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations.
L- użu ta ’ basiliximab ma jeskludix li wara tingħata kura bi preparazzjonijiet ta’ antikorpi ta ’ antilimfoċiti tal- ġurdien.
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.
Fl- istudji oriġinali ta ’ Fażi 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 ta ’ l - antikorpi (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.
Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen which included either azathioprine or mycophenolate mofetil.
Tlett provi kliniċi investigaw l- użu ta ’ basiliximab flimkien ma ’ terapija b’ kors ta ’ tlett sustanzi li kienu jinkludu azathioprine jew mycophenolate mofetil.
The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
It- tneħħija totali mill- ġisem ta ’ basiliximab naqset b’ medja ta ’ 22% meta azathioprine ngħata ma ’ kors li kien jikkonsisti f’ ciclosporin għal mikroemulsjonijiet u kortikosterojdi.
The total body clearance of basiliximab was reduced by an average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids.
It- tneħħija totali mill- ġisem ta ’ basiliximab naqset b’ medja ta ’ 51% meta mycophenolate mofetil ingħata mal- kors li kien jikkonsisti f’ ciclosporin għal mikroemulsjonijiet u kortikosterojdi.
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).
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 fil - grupp ta ’ Simulect meta mqabbla mal- grupp tal- plaċebo (ara sezzjoni 4. 8).
Simulect is contraindicated in pregnancy and lactation (see section 4.3).
Simulect m’ għandux jingħata waqt it- tqala jew treddiegħ (ara sezzjoni 4. 3).
Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk.
Basiliximab għandu effetti immunosoppressivi li jistgħu jkunu perikolużi għat- tqala u għat- tarbija tat- twelid li tkun għada qed terda ’ meta din tiġi esponuta għal basiliximab mill- ħalib tas- sider.
Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.
Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċezzjoni effettiva waqt u sa 16- il ġimgħa wara il- kura.
There is no animal or human data available concerning excretion of basiliximab into breast milk.
M’ hemm l- ebda informazzjoni fuq l- annimali jew il- bnedmin dwar jekk basiliximab joħroġx mal- ħalib tas- sider.
However, based on the IgG1 nature of basiliximab, excretion into milk should be expected.
Madankollu, minħabba n- natura IgG1 ta ’ basiliximab, l- eskrezzjoni fil- ħalib għandha tkun mistennija.
Breast- feeding must therefore be avoided.
Għalhekk omm fuq din il- kura m’ għandhiex tredda ’.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq jew tħaddem magni
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).
4 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).
Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Tagħrif fuq is- sigurtà ta ’ pazjenti pedjatriċi nkiseb minn studju farmakokinetiku u farmakodinamiku open label wieħed fuq pazjenti li kellhom trapjant renali (41 pazjent).
4 Incidence of adverse events:
L- inċidenza tal- każijiet avversi:
In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo.
Fl- erba ’ provi kontrollati bil- plaċebo t’ hawn fuq, it- tipi ta ’ każijiet avversi li dehru f’ 590 pazjent li ngħataw id- doża rakkomandata ta ’ basiliximab kienu komparabbli ma ’ dawk osservati f ’ 595 pazjent li ngħataw plaċebo.
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.
L- inċidenza globali ta ’ l- effetti avversi relatati mal - kura 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%).
Adult patients 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.
Pazjenti adulti 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 tal - ġerħa kirurġika, żieda fil- piż, żieda fil- livell tal- krejatinina fid- demm, ipofosfatimja, dijarea, u infezzjoni fl- apparat respiratorju fin- naħa ta ’ fuq.
Paediatric patients 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.
Pazjenti pedjatriċi 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 fl - apparat respiratorju fin- naħa ta ’ fuq, infezzjoni b’ vajruses, sepsis u stitikezza.
Incidence of malignant neoplasms:
L- inċidenza ta ’ neoplażmi malinni:
The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups.
L- inċidenza globali ta ’ tumuri fost il- pazjenti kollha fl- istudji individwali kienet simili bejn il- gruppi tal- kura b’ basiliximab u dawk għal skop ta ’ paragun.
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.
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.
Other malignancies were reported among 1.0% (7/ 701) of patients in the basiliximab group compared with 1.2% (7/ 595) of placebo patients.
Tumuri oħrajn dehru f’ 1. 0% (7/ 701) tal- pazjenti fil- grupp basiliximab, kontra 1. 2% (7/ 595) tal- pazjenti bil- plaċebo.
In a pooled analysis of two five- year 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).
Analiżi kollettiva ta ’ żewġ studji ta ’ ħames snin li ġew estiżi, l - inċidenza ta ’ LPDs u tumur kienet indaqs f’ basiliximab 7% (21/ 295) u fil- plaċebo 7% (21/ 291) (ara sezzjoni 4. 4).
Incidence of infectious episodes:
Inċidenza ta ’ episodji ta ’ infezzjoni:
The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups.
L- inċidenza u l- profil globali ta ’ infezzjonijiet virali, bil- batteri jew tal- fungu fost pazjenti kkurati b’ basiliximab jew plaċebo f’ kombinazzjoni ma ’ terapija immunosoppressiva bi tnejn jew bi tlieta, kienet setgħet titqabbel bejn il- gruppi.
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.
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. 1% u 24. 8% rispettivament.
The incidence of CMV infections was similar in both groups (14.6% vs.
L- inċidenza ta ’ infezzjonijiet b’ CMV kienet simili fiż- żewġ gruppi (14. 6% vs.
17.3%), following either dual or triple therapy regimen (see section 4.4).
17. 3%), wara kors ta ’ terapija bi tnejn jew bi tlieta (ara sezzjoni 4. 4).
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%).
L- inċidenza u l- kawżi ta ’ l- 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 ta ’ l- imwiet fiż- żewġ gruppi ta ’ kura tkun l- infezzjonijiet (basiliximab = 1. 3%, plaċebo = 1. 4%).
In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders (basiliximab 5%, placebo 4%).
F’ analiżi kollettiva minn żewġ studji ta ’ estensjoni fuq medda ta ’ ħames snin, l- inċidenza u l- kawża ta ’ l- imwiet baqgħu simili fiż - żewġ gruppi ta ’ kura, (basiliximab 15%, plaċebo 11%), bil- kawża primarja ta ’ l- imwiet tkun mard assoċjat mal- qalb (basiliximab 5%, plaċebo 4%).
Post-marketing adverse reactions Hypersensitivity/ anaphylactoid reactions such as rash, urticaria, sneezing, wheezing, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome (see section 4.4), and cytokine release syndrome have been reported during post-marketing experience with Simulect.
Reazzjonijiet avversi wara t- tqegħid fis- suq Reazzjonijiet ta ’ sensittività eċċessiva/ anafilaktojd bħal raxx, urtikarja, għatis, tħarħir, bronkospażmi, edema fil- pulmun, insuffiċjenza kardijaka, insuffiċjenza respiratorja u sindrome ta ’ tnixxija tal - kapillari (ara sezzjoni 4. 4), u sindrome ta ’ ħelsien ta ’ ċitokini kienu rrappurtati wara li Simulect tqiegħed fis- suq.
The frequency is not known (cannot be estimated from the available data).
Il- frekwenza mhix mgħarufa (ma tistax tiġi stmata mid- dejta disponibbli).
In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects.
5 laħqu 150 mg fuq perijodu ta ’ 24 jum mingħajr ma kien hemm l- ebda effetti akuti mhux mixtieqa.
For information on preclinical toxicology see section 5.3.
Għal tagħrif dwar tossikoloġija ta ’ qabel l- użu kliniku ara sezzjoni 5. 3.
Interleukin inhibitors, ATC code:
Impedituri ta ’ interlukin, Kodiċi ATC:
L04AC02.
L04ACO2
Mechanism of action Basiliximab is a murine/ human chimeric monoclonal antibody (IgG1 κ) that is directed against the interleukin-2 receptor α -chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge.
Mekkaniżmu ta ’ kif jaħdem Basiliximab huwa antikorp monoklonali kimeriku tal- ġurdien/ uman (IgG1κ) li huwa immirat kontra l - katina- α tar- riċettur interlukin- 2 (antiġen CD25), li hija espressa fuq is- superfiċje tal- limfoċiti- T bħala rispons għall- kuntatt ma ’ l- antiġen.
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 (IL- 2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection.
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 ta ’ l- allograft.
Complete and consistent blocking of the interleukin-2 receptor is maintained as long as serum basiliximab levels exceed 0.2 μ g/ ml (usually up to 4– 6 weeks after administration).
L - imblokkar komplet u konsistenti tar- riċettur interlukin- 2 jinżamm kemm- il darba l- livell ta ’ basiliximab fis- serum jibqa ’ ogħla minn 0. 2 μg/ ml (normalment minn 4 sa 6 ġimgħat wara li jingħata).
As concentrations fall below this level, expression of the CD25 antigen returns to pretherapy values within 1– 2 weeks.
Meta l- konċentrazzjonijiet jibdew jaqaw taħt dan il- livell, il- preżenza ta ’ l- antiġen CD25 terġa ’ lura għall- ammonti ta ’ qabel it- terapija fi żmien 1– 2 ġimgħat.
Basiliximab does not cause myelosuppression.
Basiliximab ma jikkawżax majelosuppressjoni.
Clinical studies The efficacy of basiliximab in prophylaxis of organ rejection in de novo renal transplantation has been demonstrated in double-blind placebo-controlled studies.
Studji kliniċi L- effikaċja ta ’ basiliximab biex jilqa ’ kontra riġett ta ’ organu fi trapjant renali de novo intweriet fi studji double blind kontrollati bil- plaċebo.
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.
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) and 12 (33% vs.
45%, p < 0. 001) kif ukoll fi żmien 12 (33% vs.
48%, p < 0.001) months after transplantation.
48%, p < 0. 001) - il xahar wara t- trapjant.
There was no significant difference between basiliximab and placebo-treated patients in graft survival after 6 and 12 months (at 12 months 32 graft losses on basiliximab (9%) and 37 graft losses on placebo (10%)).
Ma kien hemm l- ebda differenza sinifikanti fuq kemm dam ħaj l- organu tat- trapjant bejn pazjenti kkurati b’ basiliximab u dawk ikkurati bil- plaċebo wara 6 u 12- il xahar (fi 12- il xahar kien hemm 32 telf ta ’ trapjant b’ basiliximab (9%) u 37 trapjant kien mitluf bil- plaċebo (10%)).
The incidence of acute rejection episode was substantially lower in patients receiving basiliximab and a triple drug immunosuppressive regimen.
L- inċidenza ta ’ episodji ta ’ riġett akut kienet sostanzjalment anqas f’ pazjenti li ġew mogħtija basiliximab u kors bi tliet mediċini immunosuppressivi.
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.
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.
35%) or mycophenolate mofetil (15% vs.
35%) jew inkella mycophenolate mofetil (15% vs.
Graft loss occurred in 6% of basiliximab-treated and 10% of placebo-treated patients by 6 months.
It- telf tat- trapjant seħħ f’ 6% tal- pazjenti ikkurati b’ basiliximab u f’ 10% tal- pazjenti ikkurati bil - plaċebo fi żmien 6 xhur.
The adverse event profile remained comparable between treatment groups.
Il- profil ta ’ l- effetti ħżiena baqa ’ komparabbli bejn iż- żewġ gruppi li rċevew it- trattament.
In a pooled analysis of two five-year open-label extension studies (586 patients total) the combined graft and patient survival rates were not statistically different for the basiliximab and placebo groups.
F’ analiżi kollettiva ta ’ żewġ studji ta ’ estensjoni open label fuq medda ta ’ ħames snin (total ta ’ 586 pazjent), ir- rati ta ’ l- għejxien ta ’ pazjenti u trapjant flimkien ma kienx statistikament differenti bejn il- gruppi basiliximab u plaċebo.
Extension studies also showed that patients who experienced an acute rejection episode during the first year after transplantation experienced more graft losses and deaths over the five-year follow-up period than patients who had no rejection.
Studji ta ’ estensjoni wrew ukoll li pazjenti li kellhom episodju ta ’ riġett akut fl- ewwel sena ta ’ wara t- trapjant, tilfu aktar trapjanti u mietu numru akbar fil- perjodu tal - ħames snin ta ’ wara, minn pazjenti li ma kellhom l- ebda riġett.
These events were not influenced by basiliximab.
Dawn l- eventi ma kinux influwenzati minn basiliximab.
Paediatrics Basiliximab was used concomitantly with ciclosporin for microemulsion and steroids in an uncontrolled study in 41 paediatric de novo renal transplant recipients.
Pedjatriċi Basiliximab intuża flimkien ma ’ ciclosporin għal mikroemulsjoni u sterojdi fi studju mhux kontrollat f’ 41 reċipjent ta ’ trapjanti tal- kliewi de novo pedjatriċi.
Acute rejection occurred in 14.6% of patients by 6 months post-transplantation, and in 24.3% by 12 months.
Riġett akut seħħ f’ 14. 6% tal- pazjenti fi żmien 6 xhur wara t- trapjant, u f’ 24. 3% fi żmien 12- il xahar.
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.
Il- profil globali ta ’ l- 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.
Immunogenicity Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
6 Immonoġeniċità 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.
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.
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 għall - muromonab- CD3, kontra 4/ 34 f’ pazjenti li ngħataw muromonab- CD3 fl- istess ħin.
The available clinical data on the use of muromonab- CD3 in patients previously treated with basiliximab suggest that subsequent use of muromonab-CD3 or other murine anti-lymphocytic antibody preparations is not precluded.
L- informazzjoni klinika li hemm dwar l- użu ta ’ muromonab- CD3 f’ pazjenti li żmien qabel ingħataw basiliximab, jindikaw li l- użu ta ’ muromonab- CD3 jew preparazzjonijiet oħra ta ’ antikorp antilimfoċitiku tal - ġurdien mhuwiex prekluż f’ dawn il- pazjenti.
Adults Single-dose and multiple-dose pharmacokinetic studies have been conducted in adult patients undergoing kidney transplantation.
Adulti Studji farmakokinetiċi b’ doża waħda u b’ dożi multipli, saru fuq pazjenti adulti li kien qed ikollhom trapjant tal- kliewi.
Cumulative doses ranged from 20 mg up to 60 mg.
Dożi kumulattivi varjaw minn 20 mg sa 60 mg.
Peak serum concentration following intravenous infusion of 20 mg over 30 minutes is 7.1±5.1 mg/ l.
L- ogħla konċentrazzjonijiet fis - serum wara infużjonijiet intravenużi ta ’ 20 mg fuq 30 minuta hi ta ’ 7. 1±5. 1 mg/ l.
There is a proportional increase in Cmax and AUC from 20 mg to 60 mg, the range of single-dose administrations tested.
Fil- medda tad- dożi b’ waħda li ġew eżaminati, minn 20 mg sa 60 mg hemm żieda proporzjonali fis- Cmax u fl- AUC.
The volume of distribution at steady state was 8.6±4.1 l.
Il - volum tad- distribuzzjoni fi stat fiss kien ta ’ 8. 6±4. 1 l.
The extent and degree of distribution to various body compartments have not been fully studied.
Il- punt u l- grad ta ’ distribuzzjoni fil - kompartamenti varji tal- ġisem għadhom ma ġewx studjatii b’ mod komplet.
In vitro studies using human tissues indicate that basiliximab binds only to activated lymphocytes and macrophages/ monocytes.
Studji in vitro fejn intuża tessut uman jindikaw li basiliximab jingħaqad biss ma ’ limfoċiti u makrofaġi/ monoċiti attivati.
The terminal half-life was 7.2±3.2 days.
Il- half - life terminali kienet ta ’ 7. 2±3. 2 jiem.
Total body clearance was 41±19 ml/ h.
It- tneħħija totali mill- ġisem kienet ta ’ 41±19 ml/ siegħa.
No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients.
F’ pazjenti adulti ma jidhirx li l- piż tal- ġisem jew is- sess jaffettwa b’ mod klinikament rilevanti l- volum ta ’ distribuzzjoni jew it- tneħħija.
Elimination half-life was not influenced by age, gender, or race.
Il- half- life ta ’ l- eliminazzjoni ma ġietx influwenzata mill- età, sess jew razza.
Paediatrics The pharmacokinetics of basiliximab were assessed in 39 paediatric de novo renal transplantation patients.
Pedjatriċi Il- farmakokinetiċi ta ’ basiliximab ġew studjati f’ 39 pazjent pedjatriku bi trapjant renali de novo.
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.
Fit - tfal 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.
Distribution volume and clearance are reduced by about 50% compared to adult renal transplantation patients.
Il- volum ta ’ distribuzzjoni fi stat fiss u t- tneħħija jonqsu b’ xi 50% meta mqabbla ma ’ pazjenti adulti tat- trapjant tal- kliewi.
Disposition parameters were not influenced to a clinically relevant extent by age (1– 11 years), body weight (9– 37 kg) or body surface area (0.44 – 1.20 m2) in this age group.
L- età (1 - 11 snin), il- piż (9- 37 kg) u l- erja tas- superfiċje tal- ġisem (0. 44- 1. 20 m2) m’ affettwawx b’ mod klinikament rilevanti l- parametri ta ’ dispożizzjoni fil- grupp ta ’ dawn l- etajiet.
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.
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.
Disposition in adolescents was similar to that in adult renal transplantation patients.
Id- dispożizzjoni fl- adolexxenti kienet simili għal dik fil- pazjenti adulti bi trapjant tal- kliewi.
The relationship between serum concentration and receptor saturation was assessed in 13 patients and was similar to that characterised in adult renal transplantation patients.
Ir- relazzjoni bejn il- konċentrazzjoni fis- serum u s - saturazzjoni tar- riċetturi ġiet studjata f ’ 13- il pazjent u nstab li kienet simili għal dik karatterizzata f’ pazjenti adulti b’ trapjant renali.
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.
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.
In the 39-week study, the highest dose resulted in approximately 1,000 times the systemic exposure (AUC) observed in patients given the recommended clinical dose together with concomitant immunosuppressive therapy.
Fl- istudju ta ’ 39- ġimgħa, l- ogħla doża kkawżat esponiment sistemiku (AUC) madwar 1, 000 darba dak li nkiseb f’ pazjenti li ngħataw id- doża klinika rakkomandata flimkien ma ’ terapija immunosoppressiva.
No maternal toxicity, embryotoxicity, or teratogenicity was observed in cynomolgous monkeys following injections of up to 5 mg/ kg basiliximab administered twice weekly during the organogenesis period.
Ma ġiet osservata l- ebda tossiċità fl- omm, jew fl- embriju, jew teratoġeniċità, f’ xadini cynomolgous, wara injezzjonijiet li laħqu 5 mg/ kg ta ’ basiliximab darbtejn fil- ġimgħa waqt il- perijodu ta ’ l- iżvilupp ta ’ l- organi fl- embriju.
No mutagenic potential was observed in vitro.
In vitro, ma ġie osservat l- ebda potenzjal mutaġeniku.
Powder Potassium dihydrogen phosphate Disodium phosphate, anhydrous Sodium chloride Sucrose Mannitol (E421) Glycine
Trab Potassium dihydrogen phosphate Disodium phosphate, anhydrous Sodium chloride Sucrose Mannitol (E421) Glycine
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).
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).
Store and transport refrigerated (2°C - 8°C).
Żomm kiesaħ waqt il- ħażna u l- ġarr (2°C - 8°C).
Simulect powder Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.
Trab Simulect Kunjett tal- ħġieġ tip I bla kulur, tapp tal- lastku butyl miksi b’ fluor- resin griż, miżmum f’ postu bi strippa ta ’ aluminium fil- ġenb, tapp ċelesti ta ’ polypropylene li tiftħu b’ subgħajk, li jkun fih 20 mg basiliximab bħala trab għal soluzzjoni għall- injezzjoni jew infużjoni.
Solvent Colourless glass ampoule, type I glass, containing 5 ml water for injections.
Solvent Ampulla tal- ħġieġ bla kulur, ħġieġ tip I, li jkun fih 5 ml ilma għall- injezzjonijiet.
Simulect is also available in vials with 10 mg basiliximab.
Simulect jista ’ jinstab ukoll f’ kunjetti b’ 10 mg basiliximab.
Reconstitution To prepare the solution for infusion or injection, add 5 ml of water for injections from the accompanying ampoule aseptically to the vial containing the Simulect powder.
Rikostituzzjoni Biex tipprepara s- soluzzjoni għall- infużjoni jew għall- injezzjoni, żid 5 ml ilma għall- injezzjonijiet mill- ampulla li tiġi magħha b’ mod asettiku ġol- kunjett li fih t- trab ta ’ Simulect.
Shake the vial gently to dissolve the powder, avoiding foaming.
Ħawwad il- kunjett bil - mod biex jinħall it- trab, u tevita r- rawgħa.
It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
Huwa rakkomandat li wara r- rikostituzzjoni, is- soluzzjoni bla kulur, ċara għal opalexxenti għandha tintuża minnufih.
Reconstituted products should be inspected visually for particulate matter prior to administration.
Prodotti rikostitwiti għandhom jiġu miflija għal frak qabel ma jingħataw.
Do not use if foreign particles are present.
Tużax jekk ikun hemm xi frak.
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature.
Wara r- rikostituzzjoni, l- istabilità kimika u fiżika intweriet għal 24 siegħa f’ 2°C - 8°C jew għal 4 sigħat f’ temperatura ambjentali.
From a microbiological point of view, the product should be used immediately.
Mil - lat mikrobijoloġiku, il- prodott għandu jintuża mill- ewwel.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax mill- ewwel, il- ħinijiet tal - ħażna u l- kondizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà ta ’ min qed jużah.
Discard the reconstituted solution if not used within 24 hours.
Armi s- soluzzjoni rikostitwita jekk din ma tintużax fi żmien 24 siegħa.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ ml (5%) for infusion.
8 Is- soluzzjoni rikostitwita hija iżotonika u tista ’ tingħata bħala injezzjoni bolus jew miżjuda b’ salina normali jew b’ dextrose 50 mg/ ml (5%) għall- infużjoni sa 50 ml jew aktar.
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.
Peress li m’ hemm l- ebda informazzjoni jekk Simulect jistax jitħallat ma ’ prodotti mediċinali oħrajn li jingħataw minn ġol- vina, Simulect m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn u dejjem għandu jingħata permezz ta ’ pajp ta ’ l- infużjoni separat.
Compatibility with a number of infusion sets has been verified.
Ġie vverifikat li Simulect huwa kompatibbli ma ’ għadd ta ’ settijiet ta ’ l- infużjoni.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kwalunkwe prodott li ma jintużax jew materjal għar- rimi għandu jintrema skond il- liġijiet lokali.
MARKETING AUTHORISATION HOLDER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
09/ 10/ 1998 Date of renewal:
09/ 10/ 1998 Data tat- tiġdid:
Simulect 10 mg powder and solvent for solution for injection or infusion
Simulect 10 mg trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni
Each vial contains 10 mg basiliximab*.
Kull kunjett fih 10 mg basiliximab *.
Posology Children and adolescents (1– 17 years) In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each.
Pożoloġija Tfal u adolexxenti (1sa 17- il sena) F’ pazjenti pedjatriċi li jiżnu anqas minn 35 kg, id- doża totali rakkomandata hija ta ’ 20 mg, mogħtija f’ żewġ dożi ta ’ 10 mg kull waħda.
The second dose should be withheld in the event of a severe
It- tieni doża m’ għandhiex tingħata f’ kaz ta ’ reazzjoni ta ’
10 hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
10 sensittività eċċessiva għal Simulect jew komplikazzjonijiet wara l- operazzjoni bħal telf tat- trapjant (ara sezzjoni 4. 4).
Adults The standard total dose is 40 mg, given in two doses of 20 mg each.
Adulti Id- doża standard totali hija ta ’ 40 mg, mogħtija f’ żewġ dożi ta ’ 20 mg kull waħda.
The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).
It- tieni doża m’ għandhiex tingħata f’ każ ta ’ reazzjoni qawwija u sensittività eċċessiva għal Simulect jew komplikazzjoniiet wara l- operazzjoni bhal meta jkun hemm telf tat- trapjant (ara sezzjoni 4. 4).
For information on reconstitution, see section 6.6.
Għal informazzjoni dwar ir- rikonstituzzjoni, ara sezzjoni 6. 6.
Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as
Pazjenti li kellhom trapjant li qed jirċievu kura immunosoppressiva b’ korsijiet flimkien ma ’ basiliximab jew mingħajru għandhom riskju akbar li jiżviluppaw mard limfoproliferattiv (LPDs)
11 lymphoma) and opportunistic infections (such as cytomegalovirus, CMV).
11 (bħal- limfoma) u infezzjonijiet opportunistiċi (bħal ċitomegalovirus, CMV).
In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without combination of basiliximab (see section 4.8).
F’ analiżi miġbura minn żewġ studji ta ’ ħames snin, ma dehru l- edba żiediet fl- inċidenza ta ’ tumuri u fl- LPDs bejn korsijiet b’ immunosoppressivi flimkien ma ’ basiliximab jew mingħajru (ara sezzjoni 4. 8).
Safety data in paediatric patients have been obtained from one open-label
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
12 pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).
Tagħrif fuq is- sigurtà ta ’ pazjenti pedjatriċi nkiseb minn studju farmakokinetiku u farmakodinamiku open label wieħed fuq pazjenti li kellhom trapjant renali (41 pazjent).
Incidence of adverse events:
L- inċidenza tal- każijiet avversi:
In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects.
13 laħqu 150 mg fuq perijodu ta ’ 24 jum mingħajr ma kien hemm l- ebda effetti akuti mhux mixtieqa.
Immunogenicity Of 339 renal transplant patients treated with basiliximab and tested for anti-idiotype antibodies, 4 (1.2%) developed an anti-idiotype antibody response.
14 Immonoġeniċità 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.
14 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku