qanastek/EMEA-V3 huggingface dataset:
Start again with another vial.
Erġa ibda mill- ġdid bi fjala ġdida.
Enbrel 50 mg powder for solution for injection.
Enbrel 50 mg trab għal soluzzjoni għall- injezzjoni.
Each vial contains 50 mg of etanercept.
Kull fjala fiha 50 mg ta ’ etanercept.
Psoriatic arthritis
Artrite psorjatika
Enbrel has been shown to improve physical
Il- kura ta ’ l- artrite psorjatika attiva u progressiva f’ adulti meta r- rispons ma kienx adekwat meta ngħataw terapija b’ mediċini anti- rewmatiċi li jimmodifikaw il- marda.
83 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
80 Ankylosing spondylitis
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid 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 rewmatojde, l- artrite psorjatika, ankylosing spondylitis, psorjasi tal- plakka jew psorjasi pedjatrika tal- plakka.
Alternatively, 50 mg Enbrel 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 ntwera li huma siguri u effettivi (ara sezzjoni 5. 1).
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg Enbrel administered once weekly.
Id- doża rrakkomandata hija ta ’ 25 mg Enbrel mogħtija darbtejn fil- ġimgħa, jew 50 mg mogħtija darba fil- ġimgha.
84 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Jekk trattament mill- ġdid b’ Enbrel huwa indikat, il- gwida ta ’ hawn fuq dwar it- trattament għandha tiġi segwita.
Children and adolescents
81 Tfal u adoloxxenti
85 Tuberculosis
Tuberkulosi
Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
82 Qabel il- bidu tal- kura b’ Enbrel, il- pazjenti kollha jridu jkunu evalwati kemm għal tuberkulosi attiva kif ukoll inattiva (‘ moħbija ’).
Worsening of hepatitis C
Aggravament ta ’ epatite Ċ
86 Allergic reactions
Reazzjonijiet Allerġiċi
Immunosuppression
83 Immunosuppressjoni
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 evalwa
In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
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 kontroll.
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 randomizzat, double blind, ikkontrollat bi plaċebo f’ pazjenti adulti b’ artrite psorjatika, 184 pazjenti ngħataw ukoll multivalent pneumococcal polysaccharide vaccine fir- 4 ġimgħa.
87 Haematologic reactions
Reazzjonijiet Ematoloġiċi
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.
Għandha tingħata attenzjoni f’ pazjenti kkurati b’ Enbrel li għandhom passat ta ’ mard fiċ- ċelluli tad- demm 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.
CNS disorders
84 Mard tas- CNS
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 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 żieda 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 rrakkomandat 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.
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.
88 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Flimkien ma ’ dan, fi studju double- blind u kkontrollat bil- plaċebo f’ pazjenti adulti li kienu qed jieħdu methotrexate ukoll, kien osservat li pazjenti kkurati b’ Enbrel u b’ anakinra kellhom rata ogħla ta ’ infezzjonijiet serji (7%) u ta ’ newtropenja milli minn pazjenti kkurati b’ Enbrel biss (ara 85 sezzjonijiet 4. 4 u 4. 8).
Non-interactions
Non- interazzjonijiet
89 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Undesirable effects in adults
Reazzjonijiet mhux mixtieqa fl- adulti
Enbrel has been studied in 2,680 patients with rheumatoid arthritis in double-blind and open-label trials.
Enbrel ġie studjat f’ 2, 680 pazjent bl- artrite rewmatojde fi studji double- blind u open- label.
The proportion of patients who discontinued treatment due to adverse events was the same in both the Enbrel and placebo treatment groups; in the first active-controlled trial, the dropout rate was significantly higher for methotrexate (10%) than for Enbrel (5%).
Il- proporzjon tal- pazjenti li ma komplewx il- kura minħabba avvenimenti avversi kienu l- istess kemm fil- grupp ta ’ Enbrel kif ukoll fil- grupp tal- plaċebo; fl- ewwel 86 studju kkontrollat attivament, in- numru ta ’ pazjenti li waqqfu t- terapija kien sinjifikament aktar għoli għal methotrexate (10%) minn dak għal Enbrel (5%).
Enbrel has also been studied in 1,180 patients with plaque psoriasis for up to 6 months in 4 double-blind placebo-controlled studies.
Enbrel ġie mistħarreġ ukoll f’ 1, 180 bi psorjasi tal- plakka sa żmien 6 xhur f’ 4 studji double - blind ikkontrollati bi plaċebo.
In double-blind clinical trials comparing Enbrel to placebo, injection site reactions were the most frequent adverse events among Enbrel-treated patients.
Fi studji kliniċi double- blind fejn Enbrel ġie mqabbel ma ’ plaċebo, reazzjonijiet fis- siti ta ’ l- injezzjoni kienu l- avvenimenti avversi l- aktar frekwenti f’ pazjenti li ħadu Enbrel.
Among patients with rheumatoid arthritis treated in placebo-controlled trials, serious adverse events occurred at a frequency of 4% in 349 patients treated with Enbrel compared with 5% of 152 placebo-treated patients.
Fi studji kkontrollati bi plaċebo, fost il- pazjenti bl- artrite rewmatojde kkurati, avvenimenti avversi serji seħħew bi frekwenza ta ’ 4% f’ 349 pazjent ikkurati b’ Enbrel, imqabbla ma ’ 5% f’ 152 pazjent ikkurati bil- plaċebo.
Seizures CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions such as optic neuritis and transverse myelitis (see section 4.4)
87 Avvenimenti demajelinanti tas- CNS li jissuġġerixxu sklerożi multipla jew kundizzjonijiet demajelinanti lokalizzati bħal newrite ottika u mijelite transversa (ara sezzjoni 4. 4)
Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme
Vaskulite kutanea (li jinkludi vaskulite lewkoċitoklastika), Sindrome ta ’ Stevens- Johnson, eritema multiforme
Toxic epidermal necrolysis
Nekrolisi epidermali tossika
91 Additional information
Informazzjoni addizzjonali
Among rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis patients in placebo-controlled, active-controlled, and open-label trials of Enbrel, serious adverse events reported included malignancies (see below), asthma, infections (see below), heart failure, myocardial infarction, myocardial ischaemia, chest pain, syncope, cerebral ischaemia, hypertension, hypotension, cholecystitis, pancreatitis, gastrointestinal haemorrhage, bursitis, confusion, depression, dyspnoea, abnormal healing, renal insufficiency, kidney calculus, deep vein thrombosis, pulmonary embolism, membranous glomerulonephropathy, polymyositis, thrombophlebitis, liver damage, leucopenia, paresis, paresthesia, vertigo, allergic alveolitis, angioedema, scleritis, bone fracture, lymphadenopathy, ulcerative colitis, intestinal obstruction, eosinophilia, haematuria, and sarcoidosis.
Fost il- pazjenti li kellhom artrite rewmatojde, artrite psorjatika, ankylosing spondylitis u psorjasi tal - plakka fi studji kkontrollati bi plaċebo, ikkontrollati attivament u open- label b’ Enbrel, ġew rrappurtati reazzjonijiet avversi serji inklużi tumuri malinni (ara taħt), ażma, infezzjonijiet, (ara taħt) insuffiċjenza tal- qalb, infart mijokardijaku, iskemja mijokardijaka, uġigħ fis- sider, sinkope, iskemja ċerebrali, pressjoni għolja, pressjoni baxxa, koleċistite, pankreatite, ħemoraġija gastrointestinali, burżite, konfużjoni, dipressjoni, dispneja, fejqan annormali, insuffiċjenza renali, ġebla fil- kliewi, trombożi fil - vini fondi, emboliżmu pulmonari, nefropatija glomerulari fir- riti, polimijosite, tromboflebite, ħsara fil - fwied, lewkopenja, pareżi, paresteżja, sturdament, alveolite allerġika, anġjoedema, sklerite, ksur fl - għadam, limfadenopatija, kolite ulċerativa u ostruzzjoni fl- imsaren, eosinofilja, ematurja, u sarkojdożi.
Malignancies
88 Tumuri malinni
There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
Kien hemm total ta ’ 15- il limfoma rrappurtati f’ 5966 pazjent ittrattati b’ Enbrel fi provi kliniċi f’ artrite rewmatojde, artrite psorjatika, ankylosing spondylitis u psorjasi.
92 Serious infections
Infezzjonijiet serji
Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Infezzjonijiet serji li kellhom pazjenti kkurati b’ Enbrel, kienu jinkludu ċellulite, gastroenterite, pnewmonja, koleċistite, osteomajelite, gastrite, appendiċite, faxxite Streptokokkali, mijosite, xokk settiku,
In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Fl- esperjenza ta ’ wara l- bejgħ, madwar nofs ir - rapporti kollha ta ’ każijiet ta ’ infezzjonijiet opportunistiċi madwar id- dinja kienu infezzjonijiet fungali invażivi.
93 There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Kien hemm rapporti ta ’ każijiet rari ta ’ pazjenti, inkużi ukoll ta ’ pazjenti b’ fattur pożittiv rewmatojdu, li żviluppaw awtoantikorpi oħra flimkien ma ’ sindrome bħal tal- lupus jew raxx li huma kompatibbli ma ’ lupus tal- ġilda sottoakut jew discoid lupus bi preżentazzjoni klinika u bijopsija.
Concurrent Enbrel and anakinra treatment
90 Il- kura ta ’ Enbrel flimkien ma ’ anakinra
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/ 139) developed neutropenia (absolute neutrophil count < 1000 / mm 3).
Fi studji fejn il- pazjenti adulti kkurati b’ Enbrel fl- istess waqt li kienet għaddejja l- kura b’ anakinra, ġie osservat li kien hemm riskju ogħla ta ’ infezzjonijiet serji meta mqabbla ma ’ l- użu ta ’ Enbrel waħdu, u 2% tal- pazjenti (3/ 139) żviluppaw newtropenja (għadd assolut tan- newtrofils < 1000 / mm3).
94 arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Livelli ogħla ta ’ TNF jinstabu wkoll fis- sinovjum u qxur psorjatiku ta ’ pazjenti bl- artrite psorjatika u fis- serum u tessut sinovjali ta ’ pazjenti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni.
TNF and lymphotoxin are pro- inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75- kilodalton (p75) tumour necrosis factor receptors (TNFRs).
TNF u lymphotoxin huma cytokines pro - infjammatorji li jeħlu ma ’ żewġ tipi differenti ta ’ riċetturi fuq is- superfiċje taċ- ċelluli: ir- riċetturi tal - fattur nekrotiku għat- tumuri (TNFRs) ta ’ 55- kilodalton (p55) u 75- kilodalton (p75).
TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
TNF u lymphotoxin jinstabu l- aktar bħala homotrimers, li l- attività bijoloġika tagħhom hija dipendenti fuq “ cross- linking ” ma ’ TNFRs fuq is- superfiċje taċ- ċelluli.
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Ħafna mill- patoloġija tal- ġogi fl- artite rewmatojde u fl- immobilità tal- vertebra kawża ta ’ infjammazzjoni u patologija tal- ġilda fi psorjasi tal- plakka hi medjata minn molekuli pro - 91 infjammatorji li huma mqabbda flimkien ġo network ikkontrollat minn TNF.
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
Din is- sezzjoni tippreżenta dejta minn erba ’ studji randomised u kkontrollati li saru fuq adulti b’ artrite rewmatojde; studju wieħed fuq adulti b’ artrite psorjatika, studju wieħed fuq adulti b’ ankylosing spondylitis, studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal- plakka, u erba ’ studji fuq adulti bi psorjasi tal- plakka.
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3
Waqt l- istudju ngħata kwestjonarju jismu “ Kwestjonarju għall- Assessjar tas- Saħħa (HAQ) ”, li nkluda diżabilità, vitalità, saħħa mentali, kundizzjoni tas- saħħa ġenerali, u sotto dominji ta ’ saħħa relatati ma ’ l- artrite.
Continued durable responses have been seen for up to 48 months in open-label extension treatment trials when patients received Enbrel without interruption; longer-term experience is not available.
Baqgħu jidhru risponsi fit- tul sa 48 xahar fl - istudji open- label ta ’ kura li kompliet meta l- pazjenti ħadu Enbrel mingħajr interruzzjoni; m’ hemmx esperjenza fuq tul ta ’ żmien itwal.
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
L- effikaċja ta ’ Enbrel kien imqabbel ma ’ methotrexate fi studju randomised, ikkontrollat attivament b’ evalwazzjonijiet radjografiċi blinded bħala endpoint primarju fi 632 pazjent adult bl- artrite rewmatojde attiva (għal < 3 snin) u li qatt ma kienu ħadu kura b’ methotrexate.
In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score (JSN).
92 F’ dan l- istudju, ħsarat strutturali fil- ġogi kienu assessjati radjografikament u espressi bħala bidla fl - iSkor Totali tat- Tingiż (TSS) u l- komponenti tiegħu, l- iskor ta ’ tħassir u l- iskor tad- tidjiq fl- ispazju tal - ġogi (JSN).
RADIOGRAPHIC PROGRESSION:
PROGRESSJONI RADJOGRAFIKA:
96 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Fi studju ieħor ikkontrollat attivament, double- blind u randomised, l- effikaċja klinika, is- sigurtà, u l - progressjoni radjografika f’ pazjenti b’ RA kkurati b’ Enbrel waħdu (25 mg darbtejn f’ ġimgħa) b’ methotrexate waħdu (7. 5 sa 20 mg fil- ġimgħa, b’ doża medja ta ’ 20 mg), u Enbrel mibdi flimkien ma ’ methotrexate ġew imqabbla f’ 682 pazjent adult b’ artrite rewmatojde attiva ta ’ bejn 6 xhur u 20 sena (medjan 5 snin) li kellhom rispons anqas minn sodisfaċenti għal mill- anqas waħda mill- mediċina anti- rewmatojde li timmodifika l- marda barra methotrexate.
Patients in the Enbrel in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Il- pazjenti fil- grupp ta ’ Enbrel flimkien mat- terapija ta ’ methotrexate kellhom risponsi sinjifikament aktar għolja ta ’ ACR 20, ACR 50, ACR 70 u titjib fl- iskor tad- DAS u HAQ kemm f’ 24 kif ukoll f’ 52 ġimgħa minn pazjenti li kienu fil- gruppi ta ’ terapija b’ mediċina waħda (ir- riżultati jidhru fit- tabella ta ’ hawn taħt).
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
93 RIŻULTATI TA ’ L- EFFIKAĊJA KLINIKA WARA 12- IL XAHAR:
97 RADIOGRAPHIC PROGRESSION:
94 PROGRESSJONI RADJOGRAFIKA:
A single 50 mg/ ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
Instab li doża waħda ta ’ injezzjoni ta ’ 50 mg/ ml Enbrel kienet bijoekwivalenti għal żewġ injezzjonijiet f’ daqqa ta ’ 25 mg/ ml.
(1) distal 98 interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
(1) involviment distali interfalanġjali (DIP); (2) artrite poliartkulari (nuqqas ta ’ noduli rewmatojdi u presenza ta ’ psorijażi); (3) artrite mutilans; (4) artrite psorjatika asimmetrika; jew (5) immobilità tal - 95 vertebre li tixbaħ infjammazzjoni.
RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
RISPONSI TA ’ PAZJENTI B’ ARTRITE PSORJATIKA FI STUDJU KKONTROLLAT BI PLAĊEBO% ta ’ Pazjenti Enbrela Plaċebo
25 mg Enbrel SC twice weekly b: p  0.001, Enbrel vs. placebo c: p  0.01, Enbrel vs. placebo
25 mg Enbrel SC dabtejn f’ ġimgħa b: p < 0. 001, Enbrel vs. plaċebo c: p < 0. 01, Enbrel vs. plaċebo
Enbrel was significantly better than placebo in all measures of disease activity (p  0.001), and responses were similar with and without concomitant methotrexate therapy.
Enbrel kien sinjifikament aħjar mill- plaċebo meta tkejlet l- attività tal- marda (p < 0. 001), u r- riponsi kienu simili f’ terapija b’ Enbrel waħdu u f’ terapija flimkien ma ’ methotrexate.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p  0.001).
L- iskor ta ’ l- indiċi tad- diżabilità kien sinjifikament aħjar f’ kull punt ta ’ żmien f’ pazjenti bl- artrite psorjatika ikkurati b’ Enbrel, relatat mal - plaċebo (p < 0. 001).
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12
F’ analiżi li fiha l- pazjenti kollha li ħarġu mill- istudju għal xi raġuni kienu kkunsidrati li kienu pprogressaw, il- perċentwali ta ’ pazjenti mingħajr progressjoni (bidla fit- TSS ta ’ ≤ 0. 5) wara 12- il xahar kien ogħla fil- grupp ta ’ Enbrel meta mqabbel mal- grupp tal- plaċebo (73% vs.
47%, respectively, p ≤ .001).
47%, rispettivament, p ≤ 0. 001).
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
96 IL- MEDJA (SE) TAL- BIDLA ANNWALIZZATA MILL- LINJA BAŻI B’ PUNTEĠĠ TOTALI SHARP
Enbrel treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Il- kura b’ Enbrel irriżultat fit- titjib tal- funzjoni fiżika matul il- perjodu double- blind, u dan il- benefiċċju inżamm matul l- espożizzjoni għal tul ta ’ żmien sa sentejn.
No study has been performed in patients with psoriatic arthritis using the 50mg once weekly dosing regimen.
Ma sar l- ebda studju fejn intuża r- reġimen ta ’ dożi ta ’ 50 mg darba fil- ġimgħa f’ pazjenti b’ artrite psorjatika.
100 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
97 RISPONSI TA ’ PAZJENTI B’ ANKYLOSING SPONDYLITIS FI STUDJU KKONTROLLAT BIL- PLAĊEBO Perċentwali ta ’ Pazjenti
a: p 0.001, Enbrel vs.
a: p < 0. 001, Enbrel vs.
In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Fir- raba ’ studju, is- sigurtà u l- effikaċja ta ’ 50 mg Enbrel (żewġ injezzjonijiet SC ta ’ 25 mg) mogħtija darba fil- ġimgħa vs 25 mg Enbrel mogħtija darbtejn fil- ġimgħa kienu evalwati fi studju double- blind, ikkontrollat bi plaċebo ta ’ 356 pazjent b’ ankylosing spondylitis attiva.
101 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Studju 1 kien prova ta ’ Fażi 2 f’ pazjenti bi psorjasi tal- plakka klinikament stabbli imma attiva li tinvolvi ≥ 10% tal- erja tal- wiċċ tal- ġisem li kellhom ≥ 18- il sena.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
98 Studju 2 evalwa 652 pazjent bi psorasi tal- plakka kronika billi ntużaw l- istess kriterji ta ’ inklużjoni bħal fi studju 1 biż- żieda ta ’ minimum psoriasis area and severity index (PASI) ta ’ 10 waqt screening.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
REAZZJONIJIET TA ’ PAZJENTI BI PSORJASI FI STUDJI 2, 3 U 4 -------------------- Studju 2 ------------------ ---------------- Studju 3 ------------- ------------- Studju 4 ------------
Placebo
darbtejn
BIW
fil -
BIW Placebo BIW BIW Placebo QW
Plaċebo
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
Plaċebo n = 46
Response (%)
n= n= n=
wk
n = 196
102 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Studju 2 kellu wkoll perijodu fejn il- mediċina ma ngħatatx waqt liem żmien pazjenti li kienu kisbu titjib PASI ta ’ mill- anqas 50% f’ ġimgħa 24 kellhom it- trattament imwaqqaf.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
99 Fi studju 3, il- maġġoranza tal- pazjenti (77%) li fil- bidu nett kienu magħżula b’ mod każwali għal 50 mg darbtejn fil- ġimgħa u li kellhom id- doża tagħhom ta ’ Enbrel imnaqqsa f’ ġimgħa 12 għal 25 mg darbtejn fil- ġimgħa żammew ir- rispons PASI 75 tagħhom sa ġimgħa 36.
103 Antibodies to Enbrel
Antikorpi għal Enbrel
The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
100 Il- proporzjon ta ’ pazjenti li żviluppaw antikorpi għal etanercept fi provi li damu aktar fit- tul (sa 3. 5 snin) jiżdied maż- żmien, kif mistenni.
Additionally, the pharmacokinetics of Enbrel in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Il- farmakokinetiċi ta ’ Enbrel f’ pazjenti bl- artrite rewmatojde, f’ pazjenti b’ ankylosing spondylitis u psorjasi tal- plakka huma simili.
Cmax (2.4 mg/ l vs 2.6 mg/ l), Cmin (1.2 mg/ l vs 1.4 mg/ l) and partial AUC (297 mgh/ l vs 316 mgh/ l), were shown to be comparable in RA patients treated with 50 mg etanercept once weekly (n=21) and 25 mg etanercept twice weekly (n=16), respectively.
Profili medji tal- konċentrazzjoni fis- serum fi stat fiss f’ pazjenti b’ RA ittrattati kienu Cmax ta ’ 2. 4 mg/ l vs 2. 6 mg/ l, Cmin ta ’ 1. 2 mg/ l vs 1. 4 mg/ l, u AUC parzjali of 297 mgh/ l vs 316 mgh/ l għal 50 mg Enbrel darba fil- ġimgħa (n=21) vs 25 mg Enbrel darbtejn fil- ġimgħa (n=16), rispettivament.
In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
Fi studju open- label, single- dose, two- treatment, crossover f’ voluntiera f’ saħħithom, etanercept mogħti bħala injezzjoni waħdanija ta ’ 50 mg/ ml instab li kien bijoekwivalenti għal żewġ injezzjonijiet simultanji ta ’ 25 mg/ ml.
In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466  g hr/ ml and 474  g hr/ ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
F’ analiżi farmakokinetika tal- popolazzjoni f’ pazjenti b’ ankylosing spondylitis l- AUCs ta ’ stat fiss ta ’ etanercept kienu 466 μg* hr/ ml u 474 μg* h/ ml għal 50 mg Enbrel darba fil- ġimgħa (N= 154) u 25 mg darbtejn fil- ġimgħa (N = 148), rispettivament.
104 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Għalkemm hemm l- eliminazzjoni ta ’ radioattività fl- awrina wara t- tehid ta ’ etanercept immarkat b’ sustanza radju- attiva f’ pazjenti u f’ voluntiera, ma gietx osservata żieda fil- konċentrazzjonijiet ta ’ etanercept f’ pazjenti b’ insuffiċjenza renali jew epatika akuta.
Paediatric patients with plaque psoriasis
101 Pazjenti pedjatriċi bi psorjasi tal- plakka
105 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
6.5 Nature and contents of container
102 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Cartons contain 2, 4 or 12 vials and 4, 8 or 24 alcohol swabs.
Il- kartun fih 2, 4 jew 12- il fjala u 4, 8 jew 24 swabs ta 'l- alkoħol.
Some white foam may remain in the vial – this is normal.
Xi ftit rawgħa bajda tista ’ tibqa fil- fjala – dan hu normali.
107 1.
103 1.
Enbrel 50 mg powder and solvent for solution for injection.
Enbrel 50 mg trab u solvent għal soluzzjoni għall- injezzjoni.
108 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
104 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 ankylosing spondylitis severa u attiva u li kellhom rispons mhux adekwat għat- terapija
109 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Jekk trattament mill- ġdid b’ Enbrel huwa indikat, il- gwida ta ’ hawn fuq dwar it- trattament għandha tiġi segwita.
Children and adolescents
105 Tfal u adolexxenti
110 Tuberculosis
Tuberkulosi
Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
106 Qabel il- bidu tal- kura b’ Enbrel, il- pazjenti kollha jridu jkunu evalwati kemm għal tuberkulosi attiva kif ukoll inattiva (‘ moħbija ’).
111 Allergic reactions associated with Enbrel administration have been reported commonly.
Rapporti dwar ir- reazzjonijiet allerġiċi assoċjati ma ’ l- għoti ta ’ Enbrel huma frekwenti.
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.
107 Teżisti l- possibbiltà għal antagonisti ta ’ TNF, inkluż Enbrel, li jaffettwaw id- difiża tal- bniedem kontra infjammazzjonijiet u tumuri malinni, permess 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 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 ġuvenili żviluppaw infezzjoni tal- ġidri r- riħ u sinjali u sintomi ta ’ meninġite asettika, li ġiet megħluba mingħajr ma kien hemm sintomi wara l- marda.
112 Haematologic reactions
Reazzjonijiet Ematoloġiċi
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.
CNS disorders
108 Mard tas- CNS
113 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Flimkien ma ’ dan, fi studju double- blind u kkontrollat bil- plaċebo f’ pazjenti adulti li kienu qed jieħdu methotrexate ukoll, kien osservat li pazjenti kkurati b’ Enbrel u b’ anakinra kellhom rata ogħla ta ’ infezzjonijiet serji (7%) u ta ’ newtropenja milli minn pazjenti kkurati b’ Enbrel biss (ara 109 sezzjonijiet 4. 4 u 4. 8).
114 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
The proportion of patients who discontinued treatment due to adverse events was the same in both the Enbrel and placebo treatment groups; in the first active-controlled trial, the dropout rate was significantly higher for methotrexate (10%) than for Enbrel (5%).
Il- proporzjon tal- pazjenti li ma komplewx il- kura minħabba avvenimenti avversi kienu l- istess kemm fil- grupp ta ’ Enbrel kif ukoll fil- grupp tal- plaċebo; fl- ewwel 110 studju kkontrollat attivament, in- numru ta ’ pazjenti li waqqfu t- terapija kien sinjifikament aktar għoli għal methotrexate (10%) minn dak għal Enbrel (5%).
Seizures CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions such as optic neuritis and transverse myelitis (see section 4.4)
111 Avvenimenti demajelinanti tas- CNS li jissuġġerixxu sklerożi multipla jew kundizzjonijiet demajelinanti lokalizzati bħal newrite ottika u mijelite transversa (ara sezzjoni 4. 4)
116 Additional information
Informazzjoni addizzjonali
Malignancies
112 Tumuri malinni
117 Serious infections
Infezzjonijiet serji
118 There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Kien hemm rapporti ta ’ każijiet rari ta ’ pazjenti, inkużi ukoll ta ’ pazjenti b’ fattur pożittiv rewmatojdu, li żviluppaw awtoantikorpi oħra flimkien ma ’ sindrome bħal tal- lupus jew raxx li huma kompatibbli ma ’ lupus tal- ġilda sottoakut jew discoid lupus bi preżentazzjoni klinika u bijopsija.
Concurrent Enbrel and anakinra treatment
114 Il- kura ta ’ Enbrel flimkien ma ’ anakinra
119 arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Livelli ogħla ta ’ TNF jinstabu wkoll fis- sinovjum u qxur psorjatiku ta ’ pazjenti bl- artrite psorjatika u fis- serum u tessut sinovjali ta ’ pazjenti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni.
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Ħafna mill- patoloġija tal- ġogi fl- artite rewmatojde u fl- immobilità tal- vertebra kawża ta ’ infjammazzjoni u patologija tal- ġilda fi psorjasi tal- plakka hi medjata minn molekuli pro - 115 infjammatorji li huma mqabbda flimkien ġo network ikkontrollat minn TNF.
In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score (JSN).
116 F’ dan l- istudju, ħsarat strutturali fil- ġogi kienu assessjati radjografikament u espressi bħala bidla fl - iSkor Totali tat- Tingiż (TSS) u l- komponenti tiegħu, l- iskor ta ’ tħassir u l- iskor tad- tidjiq fl- ispazju tal - ġogi (JSN).
121 In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Fi studju ieħor ikkontrollat attivament, double- blind u randomised, l- effikaċja klinika, is- sigurtà, u l - progressjoni radjografika f’ pazjenti b’ RA kkurati b’ Enbrel waħdu (25 mg darbtejn f’ ġimgħa) b’ methotrexate waħdu (7. 5 sa 20 mg fil- ġimgħa, b’ doża medja ta ’ 20 mg), u Enbrel mibdi flimkien ma ’ methotrexate ġew imqabbla f’ 682 pazjent adult b’ artrite rewmatojde attiva ta ’ bejn 6 xhur u 20 sena (medjan 5 snin) li kellhom rispons anqas minn sodisfaċenti għal mill- anqas waħda mill- mediċina anti- rewmatojde li timmodifika l- marda barra methotrexate.
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
117 RIŻULTATI TA ’ L- EFFIKAĊJA KLINIKA WARA 12- IL XAHAR:
122 RADIOGRAPHIC PROGRESSION:
118 PROGRESSJONI RADJOGRAFIKA:
A single 50 mg/ ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
Instab li doża waħda ta ’ injezzjoni ta ’ 50 mg/ ml Enbrel kienet bioekwivalenti għal żewġ injezzjonijiet f’ daqqa ta ’ 25 mg/ ml.
(1) distal 123 interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
(1) involviment distali interfalanġjali (DIP); (2) artrite poliartkulari (nuqqas ta ’ noduli rewmatojdi u presenza ta ’ psorijażi); (3) artrite mutilans; (4) artrite psorjatika asimmetrika; jew (5) immobilità tal - 119 vertebre li tixbaħ infjammazzjoni.
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
120 IL- MEDJA (SE) TAL- BIDLA ANNWALIZZATA MILL- LINJA BAŻI B’ PUNTEĠĠ TOTALI SHARP
125 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
121 RISPONSI TA ’ PAZJENTI B’ ANKYLOSING SPONDYLITIS FI STUDJU KKONTROLLAT BIL- PLAĊEBO Perċentwali ta ’ Pazjenti
a: p 0.001, Enbrel vs.
A: p < 0. 001, Enbrel vs.
126 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Studju 1 kien prova ta ’ Fażi 2 f’ pazjenti bi psorjasi tal- plakka klinikament stabbli imma attiva li tinvolvi ≥ 10% tal- erja tal- wiċċ tal- ġisem li kellhom ≥ 18- il sena.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
122 Studju 2 evalwa 652 pazjent bi psorasi tal- plakka kronika billi ntużaw l- istess kriterji ta ’ inklużjoni bħal fi studju 1 biż- żieda ta ’ minimum psoriasis area and severity index (PASI) ta ’ 10 waqt screening.
127 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Studju 2 kellu wkoll perijodu fejn il- mediċina ma ngħatatx waqt liem żmien pazjenti li kienu kisbu titjib PASI ta ’ mill- anqas 50% f’ ġimgħa 24 kellhom it- trattament imwaqqaf.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
123 Fi studju 3, il- maġġoranza tal- pazjenti (77%) li fil- bidu nett kienu magħżula b’ mod każwali għal 50 mg darbtejn fil- ġimgħa u li kellhom id- doża tagħhom ta ’ Enbrel imnaqqsa f’ ġimgħa 12 għal 25 mg darbtejn fil- ġimgħa żammew ir- rispons PASI 75 tagħhom sa ġimgħa 36.
128 Antibodies to Enbrel
Antikorpi għal Enbrel
The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
124 Il- proporzjon ta ’ pazjenti li żviluppaw antikorpi għal etanercept fi provi li damu aktar fit- tul (sa 3. 5 snin) jiżdied maż- żmien, kif mistenni.
Cmax (2.4 mg/ l vs 2.6 mg/ l), Cmin (1.2 mg/ l vs 1.4 mg/ l), and partial AUC (297 mgh/ l vs 316 mgh/ l), were shown to be comparable in RA patients treated with 50 mg etanercept once weekly (n=21) and 25 mg etanercept twice weekly (n=16), respectively.
Profili medji tal- konċentrazzjoni fis- serum fi stat fiss f’ pazjenti b’ RA ittrattati kienu Cmax ta ’ 2. 4 mg/ l vs 2. 6 mg/ l, Cmin ta ’ 1. 2 mg/ l vs 1. 4 mg/ l, u AUC parzjali of 297 mgh/ l vs 316 mgh/ l għal 50 mg Enbrel darba fil- ġimgħa (n=21) vs 25 mg Enbrel darbtejn fil- ġimgħa (n=16), rispettivament.
129 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Għalkemm hemm l- eliminazzjoni ta ’ radioattività fl- awrina wara t- tehid ta ’ etanercept immarkat b’ sustanza radju- attiva f’ pazjenti u f’ voluntiera, ma gietx osservata żieda fil- konċentrazzjonijiet ta ’ etanercept f’ pazjenti b’ insuffiċjenza renali jew epatika akuta.
Paediatric patients with plaque psoriasis
125 Pazjenti pedjatriċi bi psorjasi tal- plakka
130 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Chemical and physical stability has been demonstrated for 48 hours at 2 – 8 C.
L- istabbilità kimika jew fiżika ntweriet għal 48 siegħa f' temperatura ta '2°C – 8°C.
If not used immediately, storage times are the responsibility of the user and should normally not be longer than 6 hours at 2 – 8 C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, il- ħinijiet ta 'ħażna huma r- responsabiltà ta' l- utent u m’ għandhomx ikunu ta ’ aktar minn 6 sigħat f’ temperatura ta ’ 2°C - 8°C, sakemm ir- rikostituzzjoni ma tkunx saret f’ kundizzjonijiet ikkontrollati u axettiċi.
6.6 Special precautions for disposal and other handling
6. 4 Prekawzjonijiet speċjali għall- ħażna
For storage conditions of the reconstituted medicinal product see section 6.3.
126 Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3.
Enbrel is supplied with pre-filled syringes containing water for injections.
Enbrel jiġi f' siringi mimlija għal- lest li fihom l- ilma għall- injezzjonijiet.
The syringes are type I glass.
Is- siringi huma tal- ħġieġ ta 'tip I.
Cartons contain 2, 4 or 12 vials of Enbrel with 2, 4 or 12 pre-filled solvent syringes, 2, 4 or 12 needles, 2, 4 or 12 vial adaptors and 4, 8 or 24 alcohol swabs.
Il- pakkett fih 2, 4 jew 12- il fjala ta ’ Enbrel bi 2, 4 jew 12- il siringa mimlija minn qabel bis - solvent, 2, 4 jew 12- il adapter tal- fjala u 4, 8 jew 24 swabs ta ’ l- alkoħol.
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
127 Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
132 1.
128 1.
Enbrel 25 mg/ ml powder and solvent for solution for injection for paediatric use.
Enbrel 25 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni għall- użu pedjatriku.
When reconstituted, the solution contains 25 mg/ ml of etanercept.
Meta rekostitwita is- soluzzjoni fiha 25 mg/ ml ta ’ etanercept.
The solution contains benzyl alcohol 9 mg/ ml as a preservative (see section 4.4).
Is- soluzzjoni fiha benzyl alkoħol 9 mg/ ml bħala preżervattiv (ara sezzjoni 4. 8).
Polyarticular juvenile idiopathic arthritis
Artrite idjopatika poliartikolari tal- minorenni
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of juvenile idiopathic arthritis or paediatric plaque psoriasis.
Il- kura b’ Enbrel għandha tinbeda taħt is- superviżjoni ta ’ tobba speċjalisti b’ esperjenza fid- dijanjosi u fil- kura tal- psorjasi tal- plakka jew psorjasi pedjatrika tal- plakka.
133 Each vial of Enbrel 25 mg/ ml should be used for a maximum of 2 doses administered to the same patient.
Kull fjala ta ’ Enbrel 25 mg/ ml għandha tintuża għal massimu ta ’ 2 dożi mogħtija lill- istess pazjent.
Comprehensive instructions for the preparation, administration and re-use of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
129 Istruzzjonijiet komprensivi għall- preparazzjoni, għoti u l- użu mill- ġdid tal- kunjett rikostitwit ta 'Enbrel huma mogħtija fil- fuljett ta' tagħrif, sezzjoni 7, “ Struzzjonijiet għall- preparazzjoni u kif tagħti injezzjoni ta ’ Enbrel ”.
Enbrel must not be given to premature babies or neonates as the solvent contains benzyl alcohol.
Enbrel m’ għandux jingħata lil trabi prematuri jew lil trabi li għadhom kif jitwieldu peress li s- solvent fih benzyl alkoħol.
134 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.
135 Concurrent Enbrel and abatacept treatment
Il- kura b’ Enbrel u abatacept fl- istess ħin
Allergic reactions
131 Reazzjonijiet Allerġiċi
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.
Huwa rakkomandat li pazjenti b’ artrite idjopatika ġuvenili, jekk huwa possibbli, jiġu aġġornati mat- tilqim kollu skond il- linji gwida tat- tilqim attwali qabel tinbeda terapija b’ Enbrel Fi studju kliniku randomizzat, 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,
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.
Haematologic reactions
132 Reazzjonijiet Ematoloġiċi
In a controlled clinical trial of two years duration in adult 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 fuq pazjenti b’ 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.
137 Wegener's granulomatosis
Granulomatożi ta ’ Wegener
Benzyl alcohol
133 Benzyl alkoħol
Enbrel contains benzyl alcohol as an excipient, which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates.
Enbrel fih benzyl alkoħol bħala sustanza mhux attiva, li jista ’ jikkawża reazzjonijiet tossiċi u reazzjonijiet anafilattojdi fit- trabi u fit- tifel/ tifla sa 3 snin ta ’ età u m’ għandux jinagħta lit- trabi prematuri u dawk li għadhom kif jitwieldu.
138 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision should be made whether to discontinue breast-feeding or to discontinue Enbrel while breast-feeding.
Minħabba li l - 134 immunoglobulini, l- istess bħal ħafna prodotti mediċinali oħra, jistgħu jitnixxu fil- ħalib ta ’ l- omm, deċiżjoni għandha tittieħed sabiex jew jitwaqqaf it- treddigħ jew jitwaqqaf Enbrel waqt it- treddigħ.