qanastek/EMEA-V3 huggingface dataset:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
53 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
What is Enbrel?
X' inhu Enbrel?
Enbrel is a medicine that contains the active substance etanercept.
Enbrel huwa mediċina li fiha s- sustanza attiva etanercept.
It is available as vials containing a powder to be made up into a solution for injection, and as prefilled syringes containing a solution for injection.
Tiġi bħala kunjetti li jkun fihom trab biex jitħallat biex jifforma soluzzjoni għall- injezzjoni, jew bħala siringa mimlija minn qabel li jkun fiha soluzzjoni għall- injezzjoni.
Each vial or syringe contains either 25 or 50 mg of etanercept.
Kull kunjett jew siringa jkun fiha 25 jew 50 mg etanercept.
What is Enbrel used for?
Għalxiex jintuża Enbrel?
Enbrel is an anti-inflammatory medicine.
Enbrel hu mediċina antinfjammatorja.
It is used for the treatment of the following diseases: • moderate to severe rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults.
Jintuża fit- trattament ta 'dan il- mard: • artrite rewmatojde moderata jew severa (marda tas- sistema immunitarja li tikkawża infjammazzjoni fil- ġogi) fl- adulti.
Enbrel is used with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments.
Enbrel jintuża ma 'methotrexate (mediċina li taħdem fuq is - sistema immunitarja) fl- adulti bil- marda f' forma moderata jew severa li ma jkunux irrispondew biżżejjed għal trattamenti oħra.
Enbrel can also be used on its own if methotrexate is not suitable for the patient.
Enbrel jista 'jintuża wkoll waħdu, jekk il- pazjent ma jkunx jista' jingħata methotrexate.
It can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before; • polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in children aged four to 17 years who have not responded adequately to or cannot take methotrexate; • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) in adults who have not responded adequately to other treatments; • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults who have not responded adequately to other treatments; • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults with moderate to severe disease and in children from the age of eight years with chronic (long-term) severe disease.
Jista 'jintuża wkoll għal pazjenti bl- artrite rewmatojde li ma jkunux ħadu methotrexate qabel. • artrite idjopatika ġuvenili poliartikulari (marda rari li tfeġġ fit- tfulija u li tikkawża infjammazzjoni f' ħafna ġogi) fi tfal ta' bejn erba ’ u 17- il sena li ma jkunux jistgħu jieħdu jew ma jkunux irrispondew kif xieraq għal methotrexate; • artrite psorijatika (marda li tikkawża rqajja 'ħomor bil- qoxra fuq il- ġilda u infjammazzjoni tal- ġogi) f' adulti li ma jkunux irrispondew kif xieraq għal trattamenti oħra; • spondilite ankilosanti severa (marda li tikkawża infjammazzjoni fil- ġogi tas- sinsla tad- dahar) f' adulti li ma jkunux irrispondew kif xieraq għal trattamenti oħra; • psorijażi bil- qoxra (marda li tikkawża rqajja' ħomor bil- qoxra fuq il- ġilda) f’ adulti bil- marda fil - forma moderata jew severa u fi tfal tal- età ta ’ tmien snin ‘ il fuq bil- marda severa kronika (fuq perjodu ta ’ żmien twil).
Enbrel is used in patients who have not responded to or cannot receive other treatments for this disease.
Enbrel jintuża f’ pazjenti li ma jkunux rrispondew jew li ma jistgħux jingħataw trattamenti oħrajn għal din il- marda.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
How is Enbrel used?
Kif jintuża Enbrel?
Enbrel treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Enbrel is used to treat.
It- trattament b' Enbrel għandu jinbeda u jiġi ssorveljat minn tabib speċjalizzat li jkollu esperjenza fid - dijanjożi u t- trattament ta 'mardiet li jista' jittratta Enbrel.
Enbrel is given by injection under the skin.
Enbrel jingħata b' injezzjoni taħt il- ġilda.
Treatment with 50 mg twice a week for up to 12 weeks can also be used
Għall- adulti, id- doża rakkomandata normalment hi 25 mg darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
It- trattament b' 50 mg darbtejn fil- ġimgħa għal 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. in psoriasis.
Reproduction is authorised provided the source is acknowledged. massimu ta ’ 12- il ġimgħa jista 'jintuża wkoll għal pazjenti bi psorijażi.
For children, the dose depends on body weight.
Għat- tfal, id- doża tiddependi fuq il- piż tal- ġisem.
The patient or carer can give the injection if they have been trained appropriately.
Il- pazjent jew min ikun qed jieħu ħsiebu jista 'jagħti l- injezzjoni hu/ hi stess, jekk ikunu ġew imħarrġa tajjeb.
For more information, see the Package Leaflet.
Għal aktar informazzjoni, ara l- Fuljett ta ’ Tagħrif.
Patients who take Enbrel must be given the special alert card that summarises important safety information about the medicine.
Il- pazjenti li jieħdu Enbrel għandhom jingħataw skeda ta 'twissija speċjali li tagħti tagħrif fil- qosor dwar is- sigurtà tal- mediċina.
How does Enbrel work?
Kif jaħdem Enbrel?
The active substance in Enbrel, etanercept, is a protein that has been designed to block the activity of a chemical messenger in the body called tumour necrosis factor (TNF).
Is- sustanza attiva f' Enbrel, etanercept, hi proteina li ġiet iddisinjata biex timblokka l- attività ta 'messaġġier kimiku fil- ġisem magħruf bħala fattur tan- nekrożi tat- tumur (tumour necrosis factor - TNF).
This messenger is found at high levels in patients with the diseases that Enbrel is used to treat.
Dan il- messaġġier jinstab f' livelli għoljin f' pazjenti li jkollhom mardiet li Enbrel jintuża biex jikkurahom.
By blocking TNF, etanercept improves the inflammation and other symptoms of the diseases.
Billi jimblokka TNF, etanercept itejjeb l- infjammazzjoni u sintomi oħra tal- mardiet.
Etanercept is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce etanercept.
Etanercept jiġi prodott b' metodu msejjaħ 'teknoloġija rikombinanti tad- DNA': hu magħmul minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha possibbli li tipproduċi etanercept.
How has Enbrel been studied?
Kif ġie studjat Enbrel?
Enbrel has been studied in five main studies in rheumatoid arthritis, involving about 2,200 patients and lasting from three months to two years.
Enbrel ġie studjat f' ħames studji ewlenin f' pazjenti bl- artrite rewmatojde, li fihom ħadu sehem madwar 2, 200 pazjent u li damu bejn tliet xhur u sentejn.
Three studies compared Enbrel with placebo (a dummy treatment) in patients who had taken anti-arthritis medicines in the past.
Dawn it- tliet studji qabblu Enbrel ma 'plaċebo (trattament finta) f' pazjenti li kienu diġà ħadu xi mediċini għal kontra l- artrite.
One of these studies examined Enbrel’ s effects as an add-on to methotrexate in 89 patients.
Wieħed minn dawn l - istudji eżamina l- effetti ta 'Enbrel bħala żieda ma ’ methotrexate f’ 89 pazjent.
In the fourth study, Enbrel was compared with methotrexate in 632 patients who had not taken methotrexate before.
Fir- raba 'studju, Enbrel tqabbel ma' methotrexate f' 632 pazjent li ma kinux ħadu methotrexate qabel.
The fifth study compared the effectiveness of Enbrel, methotrexate and a combination of both in 686 patients.
Il- ħames studju qabbel l - effikaċja ta 'Enbrel, methotrexate u kombinazzjoni tagħhom f' 686 pazjent.
In all studies, the main measure of effectiveness was the improvement of the symptoms of arthritis.
Fl- istudji kollha, il- kejl ewlieni tal- effikaċja kien it- titjib fis- sintomi tal- artrite.
Enbrel was compared with placebo in 51 children with polyarticular juvenile idiopathic arthritis, 205 adults with psoriatic arthritis, 357 adults with ankylosing spondylitis, and 1,263 adults and 211 children with plaque psoriasis.
Enbrel tqabbel ma ’ plaċebo f’ 51 tifel u tifla bl- artrite idjopatika ġuvenili poliartikulari, f’ 205 adulti bl - artrite psorijatika, f’ 357 adult bi spondilite ankilosanti, u f’ 1, 263 adult u 211- il tifel u tifla bi psorijażi bil- qoxra.
The main measure of effectiveness was the change in symptoms after three to four months.
Il- mezz ewlieni tal- kejl tal- effikaċja kien it- tibdil fis- sintomi wara tliet jew erba ’ xhur.
What benefit has Enbrel shown during the studies?
X' benefiċċju wera Enbrel matul l- istudji?
Overall, in the studies of rheumatoid arthritis, about two-thirds of the patients receiving Enbrel had a reduction in symptoms of 20% or more after three months.
B’ mod ġenerali, fl- istudji dwar l- artrite rewmatojde, madwar żewġ terzi tal- pazjenti li kienu qed jieħdu Enbrel kellhom tnaqqis fis- sintomi ta '20% jew iktar wara tliet xhur.
This compared with 23 to 33% of the patients receiving placebo.
Dan tqabbel ma 'bejn 23 u 33% tal- pazjenti li kienu qed jieħdu plaċebo.
In the study of patients who had not taken methotrexate before, those receiving 25 mg Enbrel twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months.
Fl- istudju ta 'pazjenti li kienu qed jieħdu methotrexate qabel, dawk li kienu qed jieħdu 25 mg Enbrel darbtejn f' ġimgħa kellhom inqas ħsara fil- ġogi minn dawk li kienu qed jieħdu methotrexate waħdu wara 12 u 24 xahar.
In the fifth study, Enbrel on its own or in combination with methotrexate was shown to be more effective than methotrexate alone.
Fil- ħames studju, Enbrel waħdu jew flimkien ma 'methotrexate deher li kien iktar effettiv minn methotrexate waħdu.
For all other diseases studied, Enbrel produced a greater improvement in symptoms than placebo.
Għall- mardiet l- oħra kollha li ġew studjati, Enbrel wassal għal titjib ikbar fis- sintomi mill- plaċebo.
What is the risk associated with Enbrel?
X' inhu r- riskju assoċjat ma 'Enbrel?
The most common side effects with Enbrel (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling), infections (including colds, and lung, bladder and skin infections).
L- iktar effetti sekondarji komuni ma 'Enbrel (li dehru f' iktar minn pazjent wieħed minn kull 10) huma reazzjonijiet fis- sit tal- injezzjoni (inkluż demm, tbenġil, ħmura, ħakk, uġigħ u nefħa), infezzjonijiet (inkluż irjiħat, u infezzjonijiet fil- pulmun, fil- borża tal- awrina u fil- ġilda).
Patients developing a serious infection should stop Enbrel treatment.
Il- pazjenti li żviluppaw infezzjoni serja għandhom iwaqqfu t- trattament ta 'Enbrel.
Similar side effects are seen in adults and in children.
Fit- tfal u fl- adulti dehru effetti sekondarji simili.
For the full list of all side effects reported with Enbrel, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' Enbrel, ara l- Fuljett ta 'Tagħrif.
Enbrel should not be used in people who may be hypersensitive (allergic) to etanercept or any of the other ingredients.
Enbrel m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal etanercept jew għal xi sustanza oħra tiegħu.
Enbrel must not be used in patients who have or are at risk of sepsis (serious blood infection), or in patients with infections.
Enbrel m' għandux jingħata lil pazjenti li jkunu żviluppaw jew ikollhom riskju li jiżviluppaw sepsis (infezzjoni serja fid- demm), u lanqas lil pazjenti b' infezzjonijiet.
Before using Enbrel, doctors must check that the patient is free of infection, including tuberculosis.
Qabel ma jintuża Enbrel, it- tabib għandu jiċċekkja li l- pazjent ma jkollux xi infezzjoni, inkluż it- tuberkulożi.
Why has Enbrel been approved?
Għaliex ġie approvat Enbrel?
The Committee for Medicinal Products for Human Use (CHMP) decided that Enbrel’ s benefits are greater than its risks for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Enbrel għandu iktar benefiċċji milli riskji meta jintuża għat- trattament tal- artrite rewmatojde, l- artrite idjopatika ġuvenili poliartikulari, artrite psorjatika, l- ispondilite ankilosanti u l- psorijażi bil- qoxra.
The Committee recommended that Enbrel be given marketing authorisation.
Il- Kumitat irrakkomanda li Enbrel jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Enbrel:
Tagħrif ieħor dwar Enbrel:
The European Commission granted a marketing authorisation valid throughout the European Union for Enbrel to Wyeth Europa Ltd on 3 February 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Enbrel lil Wyeth Europe Ltd fit- 3 ta 'Frar 2000.
The marketing authorisation was renewed on 3 February 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 3 ta 'Frar 2005.
2/ 3 The full EPAR for Enbrel can be found here.
2/ 3 L- EPAR sħiħ għal Enbrel jista ’ jiġi kkonsultat hawn.
This summary was last updated in 12-2008.
Dan is- sommarju kien aġġornat l- aħħar fi: 12- 2008.
Enbrel 25 mg powder and solvent for solution for injection.
Enbrel 25 mg trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial contains 25 mg of etanercept.
Kull kunjett fih 25 mg ta ’ etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Etanercept hija proteina umana b’ fattur nekrotiku għat- tumuri b’ funzjoni tar- riċettur p75 Fc, prodott b’ teknoloġija rikombinanti tad- DNA bis- sistema ta ’ espressjoni mammifera fl- ovarji ta ’ ħamster Ċiniż (CHO).
Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/ p75) to the Fc domain of human IgG1.
Etanercept huwa dimer ta ’ proteina kimerika magħmula permezz ta ’ inġinerija ġenetika bl - għaqda tad- dominju barra miċ- ċellula li jgħaqqad il- ligandi tal- fattur uman nekrotiku għat- tumuri tar - riċettur- 2 (TNFR2/ p75) mad- dominju Fc ta ’ IgG1 uman.
This Fc component contains the hinge, CH2 and CH3 regions but not the CH1 region of IgG1.
Dan il- komponiment Fc fih il- hinge, ir - reġjuni CH2 u CH3 iżda mhux ir- reġjun CH1 ta ’ IgG1.
Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Etanercept fih 934 amino aċidi u għandu toqol molekulari apparenti ta ’ bejn wieħed u ieħor 150 kilodaltons.
The potency is determined by measuring the ability of etanercept to neutralise the TNF -mediated growth inhibition of A375 cells.
Il- qawwa tiegħu hi determinata billi tkejjel l- abbiltà ta ’ etanercept biex jinnewtralizza l- impedizzjoni tat- tkabbir taċ- ċelluli A375 medjata minn TNFα.
The specific activity of etanercept is 1.7 x 106 units/ mg.
L- attività speċifika ta ’ etanercept hi 1. 7 x 106 units/ mg.
The powder is white.
It- trab hu abjad.
The solvent is a clear, colourless liquid.
Is- solvent huwa likwidu ċar mingħajr kulur.
4.1 Therapeutic indications
Indikazzjonijiet terapewtiċi 4. 1
Rheumatoid arthritis
Artrite rewmatojde
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Enbrel f’ taħlita ma ’ methotrexate huwa indikat għal trattament ta ’ artrite rewmatojde attiva moderata għal severa fl- adulti meta r- rispons għall- mediċini antirewmatiċi li jimmodifikaw il- marda, inkluż methotrexate (kemm- il darba mhux kontraindikat), kienet inadegwata.
Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enbrel jista ’ jingħata bħala monoterapija f’ kaz ta ’ intolleranza għal methotrexate jew meta trattamenti fit- tul b’ methotrexate mhux adattat.
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Enbrel huwa indikat ukoll fi trattament ta ’ artrite rewmatojde severa, attiva u progressiva fl- adulti li ma kienux ittrattati qabel b’ methotrexate.
Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Enbrel, waħdu jew f’ taħlita ma ’ methotrexate, intwera li jnaqqas ir- rata ta ’ progressjoni ta ’ ħsara fil - ġogi kif imkejla bir- raġġi X u li jtejjeb il- funzjoni fiżika.
2 Polyarticular juvenile idiopathic arthritis
Artrite idjopatika poliartikolari tal- minorenni
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 4 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Trattament ta ’ artrite idjopatika poliartikolari tal- minorenni fit- tfal u adolexxenti mill- età ta ’ 4 snin li kellhom rispons mhux adegwat għal, jew li intwera li ma jittollerawx, methotrexate.
Enbrel has not been studied in children aged less than 4 years.
Enbrel ma ġiex mistħarreġ fi tfal ta ’ età anqas minn 4 snin.
Psoriatic arthritis
2 Artrite psorjatika
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate.
Il- kura ta ’ l- artrite psorjatika attiva u progressiva f’ adulti meta r- rispons ma kienx adegwat meta ngħataw terapija b’ mediċini anti- rewmatiċi li jimmodifikaw il- marda.
Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Intwera li Enbrel itejjeb il - funzjoni fiżika f’ pazjenti b’ artrite psorjatika, u li jnaqqas ir- rata ta ’ progressjoni ta ’ ħsara periferali tal - ġogi kif imkejla bir- raġġi x f’ pazjenti b’ sotto- tipi simmetriċi poliartikulari tal- marda.
Ankylosing spondylitis
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Il- kura f’ adulti li għandhom immobilità tal- vertebre kawża ta ’ infjammazzjoni severa w attiva u li kellhom rispons mhux adekwat għat- terapija konvenzjonali.
Plaque psoriasis
Psorjasi tal- plakka
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see Section 5.1).
Trattament ta ’ adulti bi psorjasi tal- plakka minn moderata sa severa li ma rreaġixxewx għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapija sistemika oħra inkluż cyclosporine, methotrexate jew PUVA (ara Sezzjoni 5. 1).
Paediatric plaque psoriasis
Psorjasi pedjatrika tal- plakka
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Il- kura ta ’ psorjasi kronika severa tal- plakka fit- tfal u fl- adolexxenti mill- età ta ’ 8 snin, li huma kkontrollati b’ mod inadegwat minn, jew li huma intolleranti għal, terapiji jew fototerapiji sistemiċi oħrajn.
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis or paediatric plaque psoriasis.
Il- kura b’ Enbrel għandha tinbeda taħt is- superviżjoni ta ’ tobba speċjalisti b’ esperjenza fid- dijanjosi u fil- kura ta ’ l- artrite rewmatojda, artrite idjopatika ġuvenili, l- artrite psorjatika, ankylosing spondylitis, psorjasi tal- plakka jew psorjasi pedjatrika tal- plakka.
Patients treated with Enbrel should be given the Patient Alert Card.
Pazjenti kkurati b’ Enbrel għandhom jingħataw Patient Alert Card.
Enbrel is available in strengths of 25 and 50 mg.
Enbrel jiġi f’ qawwiet ta ’ 25 u 50 mg.
Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Struzzjonijiet komprensivi għall- preparazzjoni u l- għoti tal- kunjett rikostitwit ta 'Enbrel huma mogħtija fil- fuljett ta' tagħrif, sezzjoni 7, “ Struzzjonijiet għall- preparazzjoni u kif tagħti injezzjoni ta ’ Enbrel ”.
Adults (18-64 years)
Adulti (18- 64 sena)
25 mg Enbrel administered twice weekly is the recommended dose.
Id- doża rrakkomandata hija ta ’ 25 mg Enbrel mogħtija darbtejn fil- ġimgħa.
Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
B’ mod alternattiv, intwera li 50 mg mogħtija darba fil- ġimgħa huma siguri u effettivi (ara sezzjoni 5. 1).
3 Psoriatic arthritis and ankylosing spondylitis
Artrite psorjatika u ankylosing spondylitis
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Id- doża rrakkomandata hija ta ’ 25 mg Enbrel mogħtija darbtejn fil- ġimgħa, jew 50 mg mogħtija darba fil- ġimgha.
The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly.
Id- doża rrakkomandata hija ta '25 mg Enbrel mogħtija darbtejn fil- ġimgħa jew 50 mg mogħtija darba fil- ġimgħa.
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.
B’ mod alternattiv, tista ’ tingħata doża ta ’ 50 mg darbtejn fil- ġimgħa sa 12- il ġimgħa, segwita minn, jekk meħtieġ, doża ta ’ 25 mg darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks.
Trattament b’ Enbrel għandu jitkompla sakemm ikun hemm titfija, sa żmien 24 ġimgħa.
Treatment should be discontinued in patients who show no response after 12 weeks.
It- trattament għandu jiġi mwaqqaf f’ pazjenti li ma jurux rispons wara 12- il ġimgħa.
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
3 Jekk trattament mill- ġdid b’ Enbrel huwa indikat, il- gwida ta ’ hawn fuq dwar it- trattament għandha tiġi segwita.
The dose should be 25 mg twice weekly or 50 mg once weekly.
Id- doża għandha tkun ta ’ 25 mg darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
Elderly patients ( 65 years)
Pazjenti anzjani (≥ 65 sena)
No dose adjustment is required.
L- ebda tibdil fid- doża hu meħtieġ.
Posology and administration are the same as for adults 18-64 years of age.
Il- pożoloġija u l- għoti huma l- istess bħal dawk ta ’ l- adulti ta ’ 18- 64 sena.
Children and adolescents
Tfal u adoloxxenti
Juvenile idiopathic arthritis (age 4 years and above)
Artrite idjopatika ġuvenili (mill- età ta ’ 4 snin ’ il fuq)
0.4 mg/ kg (up to a maximum of 25 mg per dose) after reconstitution of 25 mg Enbrel in 1 ml of solvent, given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses.
0. 4 mg/ kg (sa massimu ta ’ 25mg għal kull doża) wara li tħallat 25 mg Enbrel f’ 1 ml ta ’ solvent, mogħtija darbtejn f’ ġimgħa bħala injezzjoni taħt il- ġilda b’ intervall ta ’ 3- 4 ijiem bejn id- dożi.
Paediatric plaque psoriasis (age 8 years and above)
Psorjasi pedjatrika tal- plakka (mill- età ta ’ 8 snin ’ il fuq)
0.8 mg/ kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks.
0. 8 mg/ kg (sa massimu ta ’ 50 mg kull doża) darba f’ ġimgħa għal sa 24 ġimgħa.
Treatment should be discontinued in patients who show no response after 12 weeks.
Il- kura għandha titwaqqaf f’ pazjenti li ma juru l- ebda rispons wara 12- il ġimgħa.
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Jekk il- kura mill- ġdid b’ Enbrel tkun indikata, il- gwida t’ hawn fuq dwar it- tul tal- kura għandha tiġi segwita.
The dose should be 0.8 mg/ kg (up to a maximum of 50 mg per dose) once weekly.
Id- doża għandha tkun ta ’ 0. 8 mg/ kg (sa massimu ta ’ 50 mg kull doża) darba f’ ġimgħa.
Renal and hepatic impairment
Indeboliment renali u epatiku
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għal sustanzi attivi jew għal xi sustanzi mhux attivi.
Sepsis or risk of sepsis.
Sepsis jew riskju ta ’ sepsis.
Treatment with Enbrel should not be initiated in patients with active infections including chronic or localised infections.
Il- kura b’ Enbrel m’ għandhiex tiġi mibdija f’ pazjenti li għandhom infezzjoni attiva, inklużi infezzjonijiet kroniċi jew lokaliżżati.
Infections
Infezzjonijiet
Patients should be evaluated for infections before, during, and after treatment with Enbrel, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Il- pazjenti għandhom ikunu evalwati għal infezzjonijiet qabel, matul, u wara l- kura b’ Enbrel, u trid tkun ikkunsidrata li l- medja ta ’ l- eliminazzjoni tal- half- life ta ’ etanercept hi ta ’ madwar 70 siegħa (medda ta ’ 7 sa 300 siegħa).
Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, have been reported with the use of Enbrel (see section 4.8).
Infezzjonijiet serji, sepsis, tuberkulosi, u infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, kienu rrappurtati bl- użu ta Enbrel (ara sezzjoni 4. 8).
These infections were due to bacteria, mycobacteria, fungi and viruses.
Dawn l- infezzjonijiet kienu kkawżati minn batterji, mikobatterji, fungi u viruses.
In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
F’ xi każijiet, infezzjonijiet partikulari fungali u infezzjonijiet opportunistiċi oħrajn ma kinux rikonoxxuti, u dan irriżulta f’ dewmien fil- kura adattata u xi kultant f’ mewt.
In evaluating patients for infections, the patient ’ s risk for relevant opportunistic infections (e. g., exposure to endemic mycoses) should be considered.
Fl- evalwazzjoni ta ’ pazjenti għal infezzjonijiet, ir- riskju tal- pazjent għal infezzjonijiet opportunistiċi rilevanti (eż. espożizzjoni għal mikożi endemika) għandu jiġi kkunsidrat.
Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
Pazjenti li jiżviluppaw infezzjoni ġdida waqt li jkunu qed jieħdu kura b’ Enbrel għandhom jiġu osservati sewwa.
Administration of Enbrel should be discontinued if a patient develops a serious infection.
L- għoti ta ’ Enbrel għandu jitwaqqaf jekk il- pazjent jiżviluppa infezzjoni serja.
Physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections such as advanced or poorly controlled diabetes.
It- tobba għandhom ikunu attenti meta jirrakkomandaw l- użu ta ’ Enbrel f’ pazjenti b’ passat ta ’ infezzjonijiet li jitfaċċaw minn żmien għall- ieħor, jew f’ pazjenti b’ infezzjonijiet kroniċi, jew f’ pazjenti 4 li għandhom kundizzjonijiet moħbija li jistgħu jżidu r- riskju għall- infezzjonijiet, per eżempju d - dijabete avvanzata jew mhux ikkontrollata bil- għaqal.
Tuberculosis
Tuberkulosi
Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with Enbrel.
Każijiet ta ’ tuberkulosi attiva li jinkludu tuberkulosi miljari u tuberkulosi b’ sit extra- pulmonari kienu rrappurtati f’ pazjenti kkurati b’ Enbrel.
Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
Qabel il- bidu tal- kura b’ Enbrel, il- pazjenti kollha jridu jkunu evalwati kemm għal tuberkulosi attiva kif ukoll inattiva (‘ moħbija ’).
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/ or current immunosuppressive therapy.
Din l- evalwazzjoni għandha tinkludi storja medika dettaljata bi storja medika personali ta ’ tuberkulosi jew kuntatt possibbli fil- passat mat- tuberkulosi, u terapija immunosoppressiva fil- passat u/ jew fil- preżent.
Appropriate screening tests, i. e. tuberculin skin test and chest x-ray, should be performed in all patients (local recommendations may apply).
Testijiet adattati ta ’ l- iscreening, i. e. test tal- ġilda tuberculin u raġġi- x tas- sider, għandhom jitwettqu fil- pazjenti kollha (rakkomandazzjonijiet lokali jistgħu japplikaw).
It is recommended that the conduct of these tests should be recorded in the patient ’ s alert card.
Hu rrakkomandat li d- data ta ’ meta jsiru dawn testijiet għandha tkun irreġistrata fil - patient’ s alert card.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Dawk li jordnaw it- testijiet huma mfakkra li jista ’ jkun hemm riskju ta ’ riżultati negattivi foloz tat- test tal- ġilda tuberculin, speċjalment f’ pazjenti li huma morda jew immunokompromessi b’ mod qawwi.
If active tuberculosis is diagnosed, Enbrel therapy must not be initiated.
Jekk tuberkulosi attiva tkun iddijanjostikata, it- terapija b’ Enbrel m’ għandhiex tinbeda.
If inactive (‘ latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Enbrel, and in accordance with local recommendations.
Jekk tkun iddijanjostikata tuberkulosi inattiva (‘ moħbija ’), għandha tinbeda kura għal tuberkulosi moħbija b’ terapija ta ’ kontra t- tuberkulosi qabel il- bidu tal- kura b’ Enbrel, u b’ konformità mar - rakkomandazzjonijiet lokali.
In this situation, the benefit/ risk balance of Enbrel therapy should be very carefully considered.
F’ din is- sitwazzjoni, il- bilanċ tal- benefiċċju / riskju tat- terapija b’ Enbrel għandu jkun ikkunsidrat b’ ħafna attenzjoni.
All patients should be informed to seek medical advice if signs/ symptoms suggestive of tuberculosis (e. g., persistent cough, wasting/ weight loss, low-grade fever) appear during or after Enbrel treatment.
Il- pazjenti kollha għandhom ikunu infurmati biex ifittxu parir mediku jekk is- sinjali/ sintomi li jissuġġerixxu li hemm tuberkulosi (eż., sogħla persistenti, dgħjufija/ telf ta ’ piż, deni mhux qawwi) jidhru matul jew wara l- kura b’ Enbrel.
Hepatitis B virus reactivation
Attivazzjoni mill- ġdid tal- virus ta ’ l- epatite B
Reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus who are receiving TNF-antagonists including Enbrel has been reported.
Kienet irrappurtata l- attivazzjoni mill- ġdid tal- virus ta ’ l- epatite B (HBV) f’ pazjenti li huma carriers kroniċi ta ’ dan il- virus u li jkunu qed jirċievu antagonisti ta ’ TNF, li jinkludu Enbrel.
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Enbrel therapy.
Pazjenti li qegħdin f’ riskju ta ’ infezzjoni bl- HBV għandhom ikunu evalwati għal evidenza fil- passat ta ’ infezzjoni bl- HBV qabel il- bidu tat- terapija b’ Enbrel.
Caution should be exercised when administering Enbrel to patients identified as carriers of HBV.
Għandha tingħata attenzjoni meta Enbrel jingħata lil pazjenti identifikati bħala carriers ta ’ HBV.
If Enbrel is used in carriers of HBV, the patients should be monitored for signs and symptoms of active HBV infection and, if necessary, appropriate treatment should be initiated.
Jekk Enbrel jintuża f’ carriers ta ’ HBV, il - pazjenti għandhom ikunu mmonitorjati għal sinjali u sintomi ta ’ infezzjoni attiva ta ’ l- HBV u, jekk ikun hemm bżonn, għandha tinbeda kura adattata.
5 Worsening of hepatitis C
Aggravament ta ’ epatite Ċ
There have been reports of worsening of hepatitis C in patients receiving Enbrel.
Kienu hemm rapporti ta ’ aggravament ta ’ epatite Ċ f’ pazjenti li kienu qed jirċievu Enbrel.
Concurrent Enbrel and anakinra treatment
Il- kura ta ’ Enbrel flimkien ma ’ anakinra
Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone.
Il- kura ta ’ Enbrel flimkien ma ’ anakinra ġiet assoċjata ma ’ żieda fir- riskju ta ’ infezzjonijiet serji u newtropenja meta mqabbla ma ’ Enbrel waħdu.
This combination has not demonstrated increased clinical benefit.
L- użu ta ’ dawn il- mediċini flimkien ma żieditx il - benefiċċju klinikali.
Thus the combined use of Enbrel and anakinra is not recommended (see sections 4.5 and 4.8).
Għalhekk l- użu ta ’ Enbrel flimkien ma ’ anakinra mhux rakkomandat (ara sezzjonijiet 4. 5 u 4. 8).
Concurrent Enbrel and abatacept treatment
Il- kura b’ Enbrel u abatacept fl- istess ħin
In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events.
Fi studji kliniċi, l- għoti ta ’ abatacept u Enbrel fl- istess ħin irriżulta f’ żieda ta ’ inċidenzi ta ’ avvenimenti avversi serji.
This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.5).
Din it- taħlita ma wrietx żieda fil- benefiċċju kliniku; użu bħal dan mhuwiex rakkomandat (ara sezzjoni 4. 5).
Allergic reactions
5 Reazzjonijiet Allerġiċi
The needle cover of the pre-filled syringe contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by or when Enbrel is administered to persons with known or possible latex sensitivity.
L- għatu tal- labra tas- siringa mimlija għal- lest fiha l- latex (gomma naturali mnixxfa) li jista ’ jikkaġuna sensittività eċċessiva meta jintmiss jew meta Enbrel jingħata lill- persuni li huma jew jistgħu ikunu sensittivi għall- latex.
Allergic reactions associated with Enbrel administration have been reported commonly.
Rapporti dwar ir- reazzjonijiet allerġiċi assoċjati ma ’ l- għoti ta ’ Enbrel huma frekwenti.
Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Ir- reazzjonijiet allerġiċi jinkludu anġjoedema u urtikarja; reazzjonijiet serji seħħew.
If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated.
Jekk xi reazzjoni allerġika serja jew anafilattika sseħħ, it- terapija ta ’ Enbrel għandha titwaqqaf immedjatament u tinbeda terapija adekwata.
Immunosuppression
Immunosuppressjoni
The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Teżisti l- possibbiltà għal antagonisti ta ’ TNF, inkluż Enbrel, li jaffettwaw id- difiża tal- bniedem kontra infjammazzjonijiet u tumuri malinni, peress li t- TNF jimmedja l- infjammazzjoni u jimmodula rispons immunitarju taċ- ċelluli.
In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Fi studju fuq 49 pazjent adult bl- artrite rewmatojde li ngħataw Enbrel, ma nstabet l- ebda evidenza ta ’ dipressjoni ta ’ sensittività eċċessiva tat- tip ritardjata, ta ’ dipressjoni tal - livelli ta ’ l- immunoglobina, jew tibdil fl- enumerazzjoni tal- popolazzjoni taċ- ċelluli tat- tip effector.
Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.
Żewġ pazjenti bl- artrite idjopatika tal- minorenni żviluppaw infezzjoni tal- ġidri r- riħ u sinjali u sintomi ta ’ meninġite asettika, li ġiet megħluba mingħajr ma kien hemm sintomi wara l- marda.
Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Pazjenti b’ espożizzjoni sinifikanti għall- virus tal- ġidri r- riħ għandhom iwaqqfu temporanjament it- terapija b’ Enbrel u jiġu kkunsidrati għall- kura profilattika b’ Varicella Zoster Immune Globulin.
The safety and efficacy of Enbrel in patients with immunosuppression or chronic infections have not been evaluated.
Is- sigurtà u l- effikaċja ta ’ Enbrel f’ pazjenti b’ immunosoppressjoni jew b’ infezzjonijiet kroniċi ma kinux evalwati.
Malignancies and lymphoproliferative disorders
Tumuri malinni u u disturbi limfoproliferattivi
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Rapporti ta ’ diversi tumuri malinni (li jinkludu karċinoma tas- sider u tal- pulmun u limfoma) kienu rrappurtati fil- perjodu ta ’ wara l- bejgħ tal- prodott mediċinali (ara sezzjoni 4. 8).
However, the
Fil- partijiet ikkontrollati ta ’ l- istħarriġ kliniku ta ’ antagonisti għal TNF, aktar każijiet ta ’ limfomi ġew osservati fost pazjenti li qed jieħdu antagonisti għal TNF meta mqabbla ma ’ pazjenti fuq kontroll.
6 occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Madankollu, il- każijiet kienu rari, u l- perijodu ta ’ follow- up ta ’ pazjenti fuq plaċebo kien iqsar milli għal pazjenti li qed jingħataw terapija antagonista għal TNF.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Barra minn hekk, hemm riskju ogħla ta ’ limfoma fl- isfond f’ pazjenti b’ artrite rewmatojde b’ mard infjammatorju, attiv ħafna u ta ’ tul ta ’ żmien li jikkomplika l- istima tar- riskju.
With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Bit- tagħrif attwali, riskju possibli għall- iżvilupp ta ’ limfomi u tumuri malinni oħra f’ pazjenti trattati b’ antagonisti għal TNF ma jistax jiġi eskluż.
Vaccinations
Tilqim
Live vaccines should not be given concurrently with Enbrel.
Vaċċini ħajjin m’ għandhomx jingħataw flimkien ma ’ Enbrel.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
M’ hemm l- ebda tagħrif dwar transmissjoni sekondarja t’ infezzjonijiet minn vaċċini ħajjin f’ pazjenti li jieħdu Enbrel.
It is recommended that juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Enbrel therapy.
Huwa rakkomandat li pazjenti b’ artrite idjopatika tal- minorenni, jekk huwa possibbli, jiġu aġġornati mat - tilqim kollu skond il- linji gwida tat- tilqim attwali qabel tinbeda terapija b’ Enbrel.
In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Fi studju kliniku b’ għażla każwali, double blind, ikkontrollat bi plaċebo f’ pazjenti adulti b’ artrite psorjatika, 184 pazjenti ngħataw ukoll multivalent pneumococcal polysaccharide vaccine fir- 4 ġimgħa.
In this study most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and few patients had two-fold rises in titers compared to patients not receiving Enbrel.
F’ dan l - istudju l- parti l- kbira tal- pazjenti b’ artrite psorjatika li kienu qed jingħataw Enbrel kienu kapaċi jibnu rispons immunoloġiku effettiv taċ- ċelloli B għal pneumococcal polysaccharide vaccine, iżda t- titrati miġbura flimkien kienu moderatament aktar baxxi u ftit pazjenti kellhom żidiet ta 'darbtejn fit- titrati mqabblin ma ’ pazjenti li mhux qegħdin jieħdu Enbrel.
The clinical significance of this is unknown.
Is- sinifikat kliniku ta ’ dan mhux magħruf.
Autoantibody formation
Formazzjoni awtoantikorpi
Treatment with Enbrel may result in the formation of autoimmune antibodies (see section 4.8).
Il- kura b’ Enbrel tista ’ tirriżulta fil- formazzjoni ta ’ antikorpi awtoimmunitarji (ara sezzjoni 4. 8).
Haematologic reactions
6 Reazzjonijiet Ematoloġiċi
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.
Ġew irrappurtati każijiet rari ta ’ panċitopenja u każijiet rari ħafna ta’ anemija aplastika, x’ uħud b’ konsegwanzi fatali, f’ pazjenti li ġew ikkurati b’ Enbrel.
Caution should be exercised in patients being treated with Enbrel who have a previous history of blood dyscrasias.
Għandha tingħata attenzjoni f’ pazjenti kkurati b’ Enbrel li għandhom passat ta ’ mard fiċ- ċelluli tad- demm.
All patients and parents/ caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e. g. persistent fever, sore throat, bruising, bleeding, paleness) whilst on Enbrel, they should seek immediate medical advice.
Il- pazjenti kollha u l- ġenituri/ dawk li jieħdu ħsiebhom għandom jingħataw parir li jekk il- pazjent jiżviluppa sinjali jew sintomi li jissuġġerixxu mard fiċ- ċelluli tad- demm jew infezzjonijiet (eż. deni persistenti, uġigħ fil- grieżem, tbenġil, fsada, sfurija), għandhom ifittxu minnufih parir mediku.
Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, Enbrel should be discontinued.
Dawn il- pazjenti għandhom jiġu investigati b’ urġenza, u jittieħed rapport sħiħ tad- demm; jekk mard fiċ- ċelluli tad- demm jiġi konfermat, Enbrel għandu jiġi mwaqqaf.
CNS disorders
Mard tal- SNĊ
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 4.8).
Rapporti dwar pazjenti kkurati b’ Enbrel u li kellhom mard demajelinanti tas- CNS huma rari (ara sezzjoni 4. 8).
Although no clinical trials have been performed evaluating Enbrel therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Għalkemm ma sar l- ebda studju kliniku biex jevalwa t- terapija ta ’ Enbrel f’ pazjenti bi sklerożi multipla, studji kliniċi ta ’ antagonisti oħra tat- TNF f’ pazjenti bi sklerożi multipla, urew żjieda fl- attività tal- marda.
A careful risk/ benefit evaluation, including a neurologic assessment, is recommended when prescribing Enbrel to patients with pre-existing or recent onset of CNS demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Evalwazzjoni serja tar- riski/ benefiċċi, flimkien ma ’ assessjar newroloġiku, hu rakkomandat meta Enbrel tingħata f’ pazjenti li diġa kellhom jew qabadhom riċentement mard demajelinanti tas- CNS, jew f’ dawk li huma kkunsidrati li għandhom riskju ogħla li jiżviluppaw mard demajelinanti.
Combination therapy
Terapija flimkien ma ’ mediċini oħra
In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of Enbrel and methotrexate did not result in unexpected safety findings, and the safety profile of Enbrel when given in combination with methotrexate was similar to the profiles reported in studies of Enbrel and methotrexate alone.
Fi studji kliniċi kkontrollati li damu sejrin sentejn f’ pazjenti bl- artrite rewmatojde, l- għoti ta ’ Enbrel flimkien ma ’ methotrexate ma rriżultax f’ sejbiet ta ’ sigurtà mhux mistennija, u l- profil tas- sigurtà ta ’ Enbrel meta mogħti flimkien ma ’ methotrexate kien simili għal profili li ġew irrappurtati fl- istudji b’ Enbrel u methotrexate waħedhom.
Long-term studies to assess the safety of the combination are ongoing.
Studji fit- tul biex ikejlu s- sigurtà ta ’ dawn il- mediċini flimkien għadhom għaddejjin.
The long- term safety of Enbrel in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Is- sigurtà fit- tul ta ’ Enbrel flimkien ma ’ mediċini oħra anti- rewmatiċi li jimmodifikaw il- marda (DMARD) għadu ma ġiex stabbilit.
7 The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
L- użu ta ’ Enbrel flimkien ma ’ terapiji sistemiċi oħrajn jew fototerapija għat- trattament ta ’ psorjasi ma ġiex mistħarreġ.
Based on pharmacokinetic data (see section 5.2), no dosage adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Meta tibbaża fuq tagħrif farmakonetiku (ara sezzjoni 5. 2), mhux meħtieġ l- ebda tibdil fid- doża f’ pazjenti b’ indeboliment renali jew epatiku; l- esperjenza klinika f’ dawn il- pazjenti hi limitata.
Congestive heart failure
Insuffiċjenza tal- qalb konġestiva
Physicians should use caution when using Enbrel in patients who have congestive heart failure (CHF).
It- tobba għandhom jkunu attenti meta jużaw Enbrel f’ pazjenti li għandhom insuffiċjenza tal- qalb konġestiva (CHF).
There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Enbrel.
Saru rapporti wara li l- mediċina ħarġet fuq is- suq ta ’ każijiet ta ’ CHF li marru għal agħar, bi jew mingħajr fatturi preċipitanti identifikabbli, f’ pazjenti li kienu fuq Enbrel.
Two large clinical trials evaluating the use of Enbrel in the treatment of CHF were terminated early due to lack of efficacy.
Żewġ studju kliniċi kbar li saru biex jevalwaw l- użu ta ’ Enbrel fil- kura tal- CHF ġew terminati kmieni minnħabba nuqqas ta ’ effikaċja.
Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Enbrel treatment.
Għalkemm ma kienux konklużi, it- tagħrif miġbur minn wieħed minn dawn l - istudji, jissuġġerixxu li hemm it- tendenza possibli li CHF tmur għall- agħar f’ pazjenti li jkunu assenjati il- kura ta ’ Enbrel.
Wegener's granulomatosis
Granulomatożi ta ’ Wegener
A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener’ s granulomatosis.
Prova kontrollata bi plaċebo, fejn 89 pazjent adult kienu ttrattati b’ Enbel ukoll barra terapija standard (inklużi cyclophosphamide u/ jew methotrexate, u glukokortikojds) fuq żmien medju ta ’ 25 xahar, ma wrietx li Enbrel huwa trattament effettiv fi granulomatożi ta ’ Wegener.
The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel than in the control group.
L- inċidenza ta ’ tumuri malinni mhux tal- ġilda ta ’ tipi varji kienet sinifikattivament ogħla għal pazjenti trattati b’ Enbrel milli għall - grupp ta ’ kontroll.
Enbrel is not recommended for the treatment of Wegener’ s granulomatosis.
Enbrel mhuwiex irrakkomandat għat- trattament ta ’ granulomatożi ta ’ Wegener.
4.5 Interaction with other medicinal products and other forms of interaction
7 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Concurrent Enbrel and anakinra treatment
Il- kura b’ Enbrel flimkien ma ’ anakinra
Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
Kien osservat li pazjenti adulti kkurati b’ Enbrel u b’ anakinra kellhom rata ogħla ta ’ infezzjonijiet serji meta mqabbla ma ’ pazjenti kkurati jew b’ Enbrel jew b’ anikra waħidhom (informazzjoni storika).