qanastek/EMEA-V3 huggingface dataset:
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Effetti mhux mixtieqa f’ pazjenti pedjatriċi bl- artrite idjopatika poliartikolari ġuvenili Ġeneralment, l- avvenimenti avversi f’ pazjenti pedjatriċi b’ artrite idjopatika ġuvenili kienu ta ’ frekwenza u tip simili għal dawk li dehru f’ pazjenti adulti.
The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
It- tipi ta ’ infezzjonijiet murija fi provi kliniċi f’ pazjenti b’ artrite idjopatika tal- minorenni ta ’ etajiet bejn 2 sa 18- il sena kienu ġeneralment ħfief għal moderati u konsistenti ma ’ dawk li komunament jidhru fil- popolazzjonijiet pedjatriċi outpatient.
139 Undesirable effects in adults
Reazzjonijiet mhux mixtieqa fl- adulti
Additionally, Enbrel has been studied in240 psoriatic arthritis patients who participated in 2 double-blind placebo- controlled studies and an open-label extension study.
Barra minn hekk, Enbrel kien studjat f’ 240 pazjent bl- artrite psorjatika li ħadu sehem f’ 2 studji 135 double- blind u kkontrollati bi plaċebo u fi studju ieħor ta ’ estensjoni open- label.
Respiratory, thoracic and mediastinal disorders:
136 Disturbi respiratorji, toraċiċi u medjastinali:
141 Serious adverse events reported in clinical trials
Avvenimenti avversi serji rrappurtati fi studji kliniċi
The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Ir- rati osservati u inċidenzi f’ dawn il- provi kliniċi kienu simili għal dawk mistennija fil- popolazzjoni 137 studjata.
142 (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Dawn kienu jinkludu qrada (f’ partijiet differenti), bakteremja, bronkite, burżite, ċellulite, koleċistite, dijarrea, divertikulite, endokardite (suspettata), gastroenterite, epatite B, herpes zoster, ulċera fis- sieq, infezzjoni fil- ħalq, osteomijelite, otitis, peritonite, pnewmonja, pajelonefrite, sepsis, artrite settika, sinużite, infezzjoni tal- ġilda, ulċera tal- ġilda, infezzjoni fil- pajpijiet ta ’ l- awrina, vaskulite, u infezzjoni fil- feriti.
Some have occurred within a few weeks after initiating treatment with Enbrel in patients who have underlying conditions (e. g. diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
138 konġestiva, passat ta ’ infezzjonijiet attivi jew kroniċi) flimkien ma ’ l- artite rewmatojde tagħhom (ara sezzjoni 4. 8).
143 Interstitial lung disease
Mard interstizjali tal- pulmun
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 / mm3).
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).
4.9 Overdose
139 4. 9 Doża eċċessiva
144 Mechanism of action
Mekkaniżmu ta ’ l- azzjoni
This section presents data from one study in polyarticular juvenile idiopathic arthritis, four studies in adults with rheumatoid arthritis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
Din is- sezzjoni fiha tagħrif meħud minn studju ta ’ pazjenti b’ artrite idjopatika tal- minorenni tat- tip poliartikulari, erba ’ studji fuq adulti b’ artrite rewmatodje, studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal- plakka, u erba ’ studji fuq adulti bi psorjasi tal- plakka.
Paediatric patients with polyarticular juvenile idiopathic arthritis
Pazjenti pedjatriċi b’ artrite poliarikolari idjopatika tal- minorenni
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types.
Is- sigurtà u l- effikaċja ta ’ Enbrel ġew assessjati fi studju maqsum f’ żewġ partijiet fejn 69 tfal b’ artrite idjopatika ġuvenili b’ kors poliartikulari, u li fil- bidu kellhom varjetà ta ’ artrite idjopatika ġuvenili.
Patients aged 4 to 17 years with moderately to severely active polyarticular juvenile idiopathic arthritis refractory to or intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti- inflammatory drug and/ or prednisone ( 0.2 mg/ kg/ day or 10 mg maximum).
140 Kienu studjati pazjenti ta ’ bejn 4 u 17- il sena b’ artrite idjopatika ġuvenili b’ kors poliartikulari bejn moderata u severament li ma fiqitx b’ methotrexate jew kienet intolleranti għal methotrexate; il - pazjenti tħallew fuq doża stabbli ta ’ mediċini kontra l- infjammazzjoni li mhumiex sterojdi u/ jew fuq prednisone (< 0. 2 mg/ kg/ kuljum jew massimu ta’ 10 mg).
In part 2, patients with a clinical response at day 90 were randomised to remain on Enbrel or receive placebo for four months and assessed for disease flare.
Fit- tieni parti, pazjenti b’ rispons kliniku fid- 90 ġurnata, kienu randomised f’ dawk li kellhom jibqgħu fuq Enbrel u f’ oħrajn biex jirċievu l- plaċebo għal erba ’ xhur u jiġu assessjati għal xi żieda qawwija fl- intensità tal - marda.
Responses were measured using the JRA Definition of Improvement (DOI), defined as  30% improvement in at least three of six and  30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/ parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Ir- rispons kien imkejjel bil- JRA Definizzjoni għat- Titjib (DOI), definita bħala ≥ 30% titjib f’ mill- inqas tlieta minn sitta, u ≥ 30% eħżen f’ mhux aktar minn wieħed minn sitta tal- kriterji bażiċi magħżula tal- JRA, li jinkludu total ta ’ ġogi attivi, limitazzjoni ta ’ ċaqliq, assessjar globali tat- tabib u tal- pazjent/ ġenitur, assessjar funzjonali u rata ta ’ sedimentazzjoni taċ- ċelloli l- ħomor tad- demm (ESR).
Studies have not been done in patients with polyarticular juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy or to assess the combination of Enbrel with methotrexate.
Ma sarux studji f’ pazjenti b’ artrite idjopatika ġuvenili b’ kors poliartikulari sabiex jiġu assessjati l - effetti tat- terapija b’ Enbrel li kompliet f’ pazjenti li ma tawx rispons fl- ewwel 3 xhur li nbdiet it - terapija ta ’ Enbrel, jew biex jiġi assessjat Enbrel flimkien ma ’ methotrexate.
Adult patients with rheumatoid arthritis
Adulti b’ artrite rewmatojde
145 ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20:
Ir- rispons ta ’ l- ACR 20 u 50 kien ogħla f’ pazjenti li ġew ikkurati b’ Enbrel għal 3 xhur u 6 xhur minn pazjenti kkurati bil- plaċebo (ACR 20:
ACR 50:
Enbrel 62% u 59%, plaċebo 23% u 11% f ’ 3 u f’ 6 xhur rispettivament; ACR 50:
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 in not available.
Baqgħu jidhru risponsi fit- tul sa 48 xahar fl - 141 istudji open- label ta ’ kura li kompliet meta l- pazjenti ħadu Enbrel mingħajr interruzzjoni; m’ hemmx esperjenza fuq tul ta ’ żmien itwal.
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 tudju 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 ’
147 CLINICAL EFFICACY RESULTS AT 12 MONTHS:
RIŻULTATI TA ’ L- EFFIKAĊJA KLINIKA WARA 12- IL XAHAR:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION Enbrel + Endpoint
Enbrel +
Methotrexate
Risponsi ACRa
(n = 231)
(n = 231) 84. 8% †, φ
ACR Responsesa
75. 0%
ACR 20 ACR 50 ACR 70
75. 8%
58.8% 36.4% 16.7%
69. 3% †, φ
65.5% 43.0% 22.0%
ACR 50
74.5% † , 63.2% † , 39.8% † ,
42. 5%
DAS
48. 4%
Baseline scoreb
42. 9% †, φ
5.5
18. 9%
5.7
24. 2%
1.1
1. 0
148 RADIOGRAPHIC PROGRESSION:
143 PROGRESSJONI RADJOGRAFIKA:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION (12 MONTH RESULTS)
TQABBIL BEJN ENBREL U METHOTREXATE U ENBREL FLIMKIEN MA ’ METHOTREXATE F’ PAZJENTI B’ RATA TA ’ BEJN 6 XHUR U 20 SENA (RIŻULTATI TA ’ 12- IL XAHAR)
Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs methotrexate, † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and  = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
p- valuri mqabbla f’ pari: * = p < 0. 05 għal Enbrel imqabbel ma ’ methotrexate, † = p < 0. 05 għal Enbrel + methotrexate mqabbel ma ’ methotrexate u φ = p < 0. 05 għal Enbrel + methotrexate mqabbel ma ’ Enbrel.
149 Adult patients with plaque psoriasis
Pazjenti adulti bi psorjasi tal- plakka
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Minflok, is- sigurtà u l- effikaċja ta ’ Enbrel kienu assessjati f’ erba ’ studji 144 magħżula b’ mod każwali, double- blind u kkontrollati bi plaċebo.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i. e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
L- endpoint ta ’ l- effikaċja primarja fl - erba ’ studji kollha kien il- proporzjon ta ’ pazjenti f’ kull grupp ta ’ trattament li kisbu PASI 75 (i. e., mill- anqas 75% titjib B’ PUNTEĠĠ tal- Psoriasis Area and Severity Index mil- linja bażi) fit- 12- il ġimgħa.
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.
Patients in this study received a dose of 50 mg Enbrel or placebo once weekly for 12 weeks and then all patients received open-label 50 mg Enbrel once weekly for an additional 12 weeks.
Pazjenti f’ dan l - istudju ngħataw doża ta ’ 50 mg Enbrel jew plaċebo darba fil- ġimgħa għal 12- il ġimgħa, u wara l- pazjenti kollha ngħataw 50 mg Enbrel open- label darba fil- ġimgħa għal 12- il ġimgħa addizzjonali.
150 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 ------------
n =
ġimgħa
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
ġimgħa Plaċebo
n = 96
n = 46 n = 96
Response (%)
n = 166
wk
n=
Among patients with plaque psoriasis who received Enbrel, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
145 Fost pazjenti b’ psorjasi tal- plakka li ngħataw Enbrel, risponsi sinifikattivi relattivi ma ’ plaċebo kienu jidhru waqt iż- żmien ta ’ l- ewwel viżta (2 ġimgħat) u kienu miżmumin waqt l- 24 ġimgħa tat- terapija.
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.
151 Patients received Enbrel 0.8 mg/ kg (up to 50 mg) or placebo once weekly for 12 weeks.
Il- pazjenti rċivew Enbrel 0. 8 mg/ kg (sa 50 mg) jew il- plaċebo darba f’ ġimgħa għal 12- il ġimgħa.
Antibodies to Enbrel
146 Antikorpi għal Enbrel
152 Paediatric patients with polyarticular juvenile idiopathic arthritis
Pazjenti pedjatriċi b’ artrite poliarikolari idjopatika tal- minorenni
In a polyarticular juvenile idiopathic arthritis trial with Enbrel, 69 patients (aged 4 to 17 years) were administered 0.4 mg Enbrel/ kg twice weekly for three months.
Fi prova b’ Enbrel dwar artrite poliartikolari idjopatika tal- minorenni, 69 pazjent (f' etajiet ta ’ 4 sa 17- il sena) ġew mogħtija 0. 4 mg Enbrel/ kg darbtejn fil- ġimgħa għal tliet xhur.
Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients.
Profili ta ’ konċentrazzjonijiet fis- serum kienu simili għal dawk li jidhru f’ pazjenti adulti b’ artrite rewmatojde.
The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults.
L- iżgħar tfal (età ta ’ 4 snin) kellhom eliminazzjoni mnaqqsa (żieda fl- eliminazzjoni meta normalizzata bil- piż) meta mqabbla ma ’ tfal akbar (età ta ’ 12- il sena) u adulti.
Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Simulazzjoni ta ’ l- iddożar tissuġġerixxi li waqt li tfal akbar (ta 'etajiet bejn 10- 17- il sena) ikollhom livelli fis- serum viċin ta ’ dawk li jidhru fl- adulti, tfal iżgħar jkollhom livelli aktar baxxi b’ mod apprezzabbli.
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 u f’ pazjenti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni u psorjasi tal- plakka huma simili.
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.
153 Methotrexate has no effect on the pharmacokinetics of etanercept.
Methotrexate m’ għandu l- ebda effett fuq il- farmakokinetiċi ta ’ etanercept.
Solvent:
148 Solvent:
Water for injections Benzyl alcohol.
Ilma għall- injezzjoni Benzyl alkoħol.
After reconstitution, chemical and physical stability has been demonstrated for 14 days at 2 C – 8 C.
Wara li jiġi rikostitwit, l- istabbilità kimika jew fiżika ntweriet għal 14- il ġurnata f’ temperatura ta ’ 2°C – 8°C.
From a microbiological point of view, once reconstituted, the product may be stored for a maximum of 14 days at 2 C – 8 C.
Mil- lat mikrobijoloġiku, wara li jiġi rikostitwit il- prodott jista ’ jinħażen għal massimu ta ’ 14- il ġurnata f' temperatura ta '2°C - 8°C.
Other storage times and conditions are the responsibility of the user.
Jekk ma jintużax minnufih, il- ħinijiet ta 'ħażna huma r - responsabiltà ta' l- utent.
154 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Enbrel is supplied with pre-filled syringes containing bacteriostatic water for injections.
Enbrel jiġi bħala siringi mimlija għal- lest li fihom ilma batterjostatiku għall- injezzjoni.
The syringes are type I glass-fitted with stainless steel needles.
Is- siringi huma tal- ħġieġ tat- tip I b’ labar ta ’ l- istainless steel.
Cartons contain 4 vials of Enbrel with 4 pre-filled solvent syringes, 8 empty plastic syringes, 20 stainless steel needles and 24 alcohol swabs.
Pakett fih 4 fjali ta ’ Enbrel b’ 4 siringi mimlija għal - lest bis- solvent, 8 siringi tal- plastik vojta, 20 labra ta ’ l- istainless steel u 24 swabs ta ’ l- alkoħol.
Enbrel is reconstituted with 1 ml bacteriostatic water for injections before use, and administered by subcutaneous injection.
Enbrel hu rikostitwit b’ 1 ml ilma batterjostatiku għall- injezzjonijiet qabel jintuża, u jiġi mogħti b' injezzjoni subkutaneja.
The solution should be clear and colourless to pale yellow, with no lumps, flakes or particles.
Is- soluzzjoni għandha tkun ċara u bla kulur għal isfar ċar, bla għoqod, biċċiet jew frak.
Enbrel should not be used if all the powder in the vial is not dissolved within 10 minutes.
Tużax Enbrel jekk mhux it- trab kollu jkun inħall fi żmien 10 minuti.
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.
Struzzjonijiet 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 ”.
155 1.
150 1.
Enbrel 25 mg solution for injection in pre-filled syringe.
Enbrel 25 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Each pre-filled syringe contains 25 mg of etanercept.
Kull siringa mimlija għal- lest fiha 25 mg ta 'etanercept.
The solution is clear, and colourless or pale yellow (see section 6.5).
Is- soluzzjoni hija ċara, mingħajr kulur jew isfar ċar (ara sezzjoni 6. 5).
156 Polyarticular juvenile idiopathic arthritis
Artrite idjopatika poliartikolari tal- minorenni
Psoriatic arthritis
151 Artrite psorjatika
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 rewmatojde, artrite idjopatika ġuvenili, l- artrite psorjatika, ankylosing spondylitis psorjasi tal- plakka jew psorjasi pedjatrika tal- plakka.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Struzzjonijiet komprensivi għall- għoti huma mogħtija fil- fuljett ta 'tagħrif, sezzjoni 7, “ Struzzjonijiet għall- preparazzjoni u kif tagħti injezzjoni ta ’ Enbrel ”.
157 Plaque psoriasis
Psorjasi tal- plakka
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
152 Jekk trattament mill- ġdid b’ Enbrel huwa indikat, il- gwida ta ’ hawn fuq dwar it- trattament għandha tiġi segwita.
No dose adjustment is required.
L- ebda aġġustament fid- doża m' hu rrakkomandat.
Posology and administration are the same as for adults 18-64 years of age.
Il- pożoloġija u l- għoti huma l- istess bħal ta ’ adulti ta ’ etajiet ta ’ bejn 18- 64 sena.
Enbrel is available as a single use syringe for patients weighing 62.5 kg or more.
Enbrel hu disponibbli bħala siringa li tintuża dabra biss għal pazjenti li jiżnu 62. 5 kg jew aktar.
Lyophilized vials containing a reconstituted dose of 25 mg/ ml are available from which doses less than 25 mg can be administered.
Kunjetti lajofilizzati li fihom doża rikostitwita ta ’ 25 mg/ ml huma disponibbli, li minnhom jista ’ jingħataw dożi ta ’ inqas minn 25 mg.
0.4 mg/ kg (up to a maximum of 25 mg per dose) given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses.
0. 4 mg/ kg (sa massimu ta ’ 25 mg kull doża) wara r- rikostituzzjoni ta ’ 25 mg Enbrel f’ 1 ml ta ’ solvent, mogħti darbtejn fil- ġimgħa bħala injezzjoni taħt il- ġilda b’ intervall ta ’ 3- 4 ijiem bejn id- dożi.
158 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
153 Pazjenti li jiżviluppaw infezzjoni ġdida waqt li jkunu qed jieħdu kura b’ Enbrel għandhom jiġu osservati sewwa.
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 li għandhom kundizzjonijiet moħbija li jistgħu jżidu r- riskju għall- infezzjonijiet, per eżempju d - dijabete avvanzata jew mhux ikkontrollata bil- għaqal.
159 Worsening of hepatitis C
Aggravament ta ’ epatite Ċ
Concurrent Enbrel and abatacept treatment
154 Il- kura b’ Enbrel u abatacept fl- istess ħin
If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated.
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.
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 niexfa) li tista ’ tikkawża reazzjonijiet ta 'sensittività eċċessiva meta tintuża jew meta Enbrel jingħata lil persuni magħrufin li għandhom jew possibilment għandhom sensittività għal- latex.
160 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 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
161 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.
Wegener's granulomatosis
156 Granulomatożi ta ’ Wegener
162 Non-interactions
Non- interazzjonijiet
Use during lactation
157 L- użu ta ’ Enbrel meta l- omm tredda
163 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.
Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)* Uncommon:
Infezzjonijiet (inklużi infezzjonijiet fis- sistema respiratorja ta ’ fuq, bronkite, ċistite, infezzjonijiet tal- ġilda) * 158
164 Skin and subcutaneous tissue disorders:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Common:
Ħakk Komuni:
Pruritus Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset and pustular, primarily palms & soles)
Anġjoedema, urtikarja, raxx, raxx psorjasiformi, psorjasi (li tinkludi bidu ġdid u bil- ponot, primarjament fil- keffa ta ’ l- id u fil- qiegħ tas- saqajn)
Cardiac disorders:
159 Disturbi fil- qalb:
165 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.
Serious infections
160 Infezzjonijiet serji
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.
161 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.
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Effetti mhux mixtieqa f’ pazjenti pedjatriċi bl- artrite idjopatika poliartikolari ġuvenili
167 The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
It- tipi ta ’ infezzjonijiet murija fi provi kliniċi f’ pazjenti b’ artrite idjopatika tal- minorenni ta ’ etajiet bejn 2 sa 18- il sena kienu ġeneralment ħfief għal moderati u konsistenti ma ’ dawk li komunament jidhru fil- popolazzjonijiet pedjatriċi outpatient.
Undesirable effects in paediatric patients with plaque psoriasis
162 Effetti mhux mixtieqa f’ pazjenti pedjatriċi bi psorjasi tal- plakka
168 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.
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in polyarticular juvenile idiopathic 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 fiha tagħrif meħud minn erba ’ studji randomised u kkontrollati f’ adulti b’ artrite rewmatojde; studju wieħed ta ’ pazjenti b’ artrite idjopatika ġuvenili tat- tip poliartikulari, studju wieħed 163 ta ’ adulti b’ artrite psorjatika, u studju wieħed ta ’ adulti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni, studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal- plakka, u erba ’ studji ta ’ adulti bi psorjasi tal- plakka.
RADIOGRAPHIC PROGRESSION:
164 PROGRESSJONI RADJOGRAFIKA:
170 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:
165 RIŻULTATI TA ’ L- EFFIKAĊJA KLINIKA WARA 12- IL XAHAR:
171 RADIOGRAPHIC PROGRESSION:
166 PROGRESSJONI RADJOGRAFIKA:
Patients aged 4 to 17 years with moderately to severely active polyarticular juvenile idiopathic arthritis refractory to or
Kienu studjati pazjenti ta ’ bejn 4 u 17- il sena b’ artrite idjopatika ġuvenili b’ kors poliartikulari bejn moderata u severament li ma fiqitx b’ methotrexate jew kienet intolleranti għal methotrexate; il - pazjenti tħallew fuq doża stabbli ta ’ mediċini kontra l- infjammazzjoni li mhumiex sterojdi u/ jew fuq prednisone (< 0. 2 mg/ kg/ kuljum jew massimu ta’ 10 mg).
In part 2, patients with a clinical response at day 90 were randomised to remain on Enbrel or receive placebo for four months and assessed for disease flare.
Fit- tieni parti, 167 pazjenti b’ rispons kliniku fid- 90 ġurnata, kienu randomised f’ dawk li kellhom jibqgħu fuq Enbrel u f’ oħrajn biex jirċievu l- plaċebo għal erba ’ xhur u jiġu assessjati għal xi żieda qawwija fl- intensità tal - marda.
173 RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
168 RISPONSI TA ’ PAZJENTI B’ ARTRITE PSORJATIKA FI STUDJU KKONTROLLAT BI PLAĊEBO% ta ’ Pazjenti Enbrela Plaċebo
174 MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
IL- MEDJA (SE) TAL- BIDLA ANNWALIZZATA MILL- LINJA BAŻI B’ PUNTEĠĠ TOTALI SHARP
No study has been performed in patients with psoriatic arthritis using the 50mg once weekly dosing regimen.
169 Ma sar l- ebda studju fejn intuża r- reġimen ta ’ dożi ta ’ 50 mg darba fil- ġimgħa f’ pazjenti b’ artrite psorjatika.
175 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
RISPONSI TA ’ PAZJENTI B’ ANKYLOSING SPONDYLITIS FI STUDJU KKONTROLLAT BIL- PLAĊEBO Perċentwali ta ’ Pazjenti
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.
170 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.
176 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.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
171 REAZZJONIJIET TA ’ PAZJENTI BI PSORJASI FI STUDJI 2, 3 U 4 -------------------- Studju 2 ------------------ ---------------- Studju 3 ------------- ------------- Studju 4 ------------
177 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.
Patients received Enbrel 0.8 mg/ kg (up to 50 mg) or placebo once weekly for 12 weeks.
172 Il- pazjenti rċivew Enbrel 0. 8 mg/ kg (sa 50 mg) jew il- plaċebo darba f’ ġimgħa għal 12- il ġimgħa.
178 Antibodies to Enbrel
Antikorpi għal Enbrel
179 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 polyarticular juvenile idiopathic arthritis
Pazjenti bl- artrite idjopatika ġuvenili b’ kors poliartikulari
In a polyarticular juvenile idiopathic arthritis trial with Enbrel, 69 patients (aged 4 to 17 years) were administered 0.4 mg Enbrel/ kg twice weekly for three months.
Fi studji b’ Enbrel fuq 69 pazjent (ta ’ eta` ta ’ bejn 4 u 17- il sena) bl- artrite idjopatika ġuvenili b’ kors poliartikulari, 0. 4 mg/ kg Enbrel kien mogħti darbtejn f’ ġimgħa għal tliet xhur.
These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice weekly.
Dawn il- konċentrazzjonijiet 174 medji kienu simili għal dawk osservati f’ pazjenti adulti bi psorjasi tal- plakka kkurati b’ 25 mg ta ’ etanercept darbtejn f’ ġimgħa.
Sucrose Sodium chloride L-Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Water for injections
Sucrose Sodium chloride L- Arginine hydrochloride Sodium phosphate monobasic dihydrate Sodium phosphate dibasic dihydrate Ilma għall- injezzjoni
Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Fjala tal- ħġieġ ċara (ħġieġ ta 'tip 1) b’ labra ta ’ l- istainless steel, labra tal- lasktu u planġer tal- plastik.
Cartons contain 4, 8 or 24 pre-filled syringes of Enbrel and 8, 16, or 48 alcohol swabs.
Il - kaxxa fiha 4, 8 jew 24 siringa mimlija għal- lest ta ’ Enbrel u 8, 16 jew 48 swab ta ’ l- alkoħol.
The needle cover contains dry natural rubber (latex) (see section 4.4).
L- għatu tal- labra fih lasktu naturali niexef (latex) (ara sezzjoni 4. 8).
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skopijiet kummerċjali.
6.6 Special precautions for disposal and other handling
Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor 6. 6
Instructions for use and handling
175 Struzzjonijiet għall- użu u maniġġar u għar- rimi
Before injection, Enbrel single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes).
Qabel l- injezzjoni, is- siringa mimlija għal- lest għal użu ta ’ darba ta ’ Enbrel għandha titħalla tikseb it - temperatura tal- kamra (madwar 15 sa 30 minuta).
The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature.
L- għatu tal- labra m’ għandux jitneħħa sakemm is - siringa mimlija għal- lest tikseb it- temperatura tal- kamra.
The solution should be clear and colourless or pale yellow and practically free from visible particles.
Is- soluzzjoni għandha tkun ċara u mingħajr kulur sa isfar ċar u prattikament ħielsa minn kull partiċella viżibbli.
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Ir- Renju Unit
182 1.
176 1.
Enbrel 50 mg solution for injection in pre-filled syringe.
Enbrel 50 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Each pre-filled syringe contains 50 mg of etanercept.
Kull siringa mimlija għal- lest fiha 50 mg ta 'etanercept.
183 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
177 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 w attiva u li kellhom rispons mhux adekwat għat- terapija
184 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
178 Tfal u adoloxxenti
No dose adjustment is required.
Indeboliment renali u epatiku
185 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.
Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
179 Qabel il- bidu tal- kura b’ Enbrel, il- pazjenti kollha jridu jkunu evalwati kemm għal tuberkulosi attiva kif ukoll inattiva (‘ moħbija ’).
186 Concurrent Enbrel and abatacept treatment
Il- kura b’ Enbrel u abatacept fl- istess ħin
Immunosuppression
180 Immunosuppressjoni
187 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.
CNS disorders
181 Mard tal- SNĊ
Two large clinical trials evaluating the use of Enbrel in the treatment of
Żewġ studju kliniċi kbar li saru biex jevalwaw l- użu ta ’ Enbrel fil- kura tal- CHF ġew terminati kmieni minnħabba nuqqas ta ’ effikaċja.
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 182 sezzjonijiet 4. 4 u 4. 8).
Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general
M’ hemm l- ebda tagħrif prekliniku dwar tossiċità ta ’ etanercept qabel jew wara l- wild, u l - effetti ta ’ etanercept fuq il- fertilità u l- abiltà ġenerali riproduttiva.
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 183 avvenimenti avversi kienu l- istess kemm fil- grupp ta ’ Enbrel kif ukoll fil- grupp tal- plaċebo; fl- ewwel studju kkontrollat attivament, in- numru ta ’ pazjenti li waqqfu t- terapija kien sinjifikament aktar għoli għal methotrexate (10%) minn dak għal Enbrel (5%).
190 common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000); not known (could not be accurately estimated through clinical studies).
Fost il- klassijiet tas- sistema ta ’ l- organi, ir- risponsi avversi huma elenkati skond il- frekwenza (numru ta ’ pazjenti mistennija li jesperjenzaw ir- rispons) skond dawn il- kategoriji: komuni ħafna (> 1/ 10); komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1000, < 1/ 100); rari (> 1/ 10, 000, < 1/ 1000); rari ħafna (< 1/ 10, 000); mhux magħrufa (ma jisgħux ikunu stmati bi preċiżjoni minn studji kliniċi).
Nervous system
Disturbi fis- sistema nervuża:
Seizures CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions such as optic neuritis and transverse myelitis (see section 4.4)
Konvulżjonijiet 184 Avvenimenti demajelinanti tas- CNS li jissuġġerixxu sklerożi multipla jew kundizzjonijiet demajelinanti lokalizzati bħal newrite ottika u mijelite transversa (ara sezzjoni 4. 4)
191 General disorders and administration site conditions:
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata:
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 b’ 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
185 Tumuri malinni
Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of
Addizzjonalment, xi ftit pazjenti żviluppaw mill- ġdid reazzjonijiet fis- siti ta ’ l- injezzjoni kkaratterizzati b’ rispons tal- ġilda fis- siti ta ’ l- injezzjoni l- aktar riċenti flimkien mad- dehra simultanja ta ’ reazzjonijiet fis- siti ta ’ l - injezzjoni f’ sit ta ’ injezzjonjiet li ngħataw qabel.
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of
Il- perċentwal ta ’ pazjenti li żviluppaw antikorpi ġodda u pożittivi tat - tip anti- DNA b’ fili doppji kien ukoll aktar għoli b’ analiżi radjo- immunoloġika (15% tal- pazjenti kkurati b’ Enbrel imqabbel ma ’ 4% tal- pazjenti kkurati bil- plaċebo) u minn analiżi bi Crithidia luciliae (3% tal- pazjenti kkurati b’ Enbrel imqabbel ma ’ ebda pazjent ikkurat bil- plaċebo).
Concurrent Enbrel and anakinra treatment
187 Il- kura ta ’ Enbrel flimkien ma ’ anakinra
194 Pharmacotherapeutic group:
Grupp Farmakoterapewtiku:
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 - 188 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 polyarticular juvenile idiopathic 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 f’ pazjenti b’ artrite idjopatika ġuvenili poliartikulari, 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.
Among patients receiving Enbrel, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always
Fost il- pazjenti li ħadu Enbrel, ir- risponsi kliniċi ġeneralment dehru wara ġimgħa jew tnejn li kienet bdiet it- terapija u kważi dejjem seħħet sa 3 xhur.
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).
189 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).
197 CLINICAL EFFICACY RESULTS AT 12 MONTHS:
190 RIŻULTATI TA ’ L- EFFIKAĊJA KLINIKA WARA 12- IL XAHAR:
198 RADIOGRAPHIC PROGRESSION:
191 PROGRESSJONI RADJOGRAFIKA:
(1) distal 199 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 - 192 vertebre li tixbaħ infjammazzjoni.
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
193 IL- MEDJA (SE) TAL- BIDLA ANNWALIZZATA MILL- LINJA BAŻI B’ PUNTEĠĠ TOTALI SHARP
The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of  30 for average of duration and intensity of morning stiffness plus VAS scores of  30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
L- akbar numru f ’ dawn l- istudji (n= 277) kienu pazjenti ta ’ bejn it- 18- il u s- 70 sena u li kellhom ankylosing spondylitisankylosing spondylitis attiva definita bħala skala analoga viżwali (VAS) bi skor ta’ ≥ 30 għal użu ta ’ żmien medju u intensità ta ’ ebbusija ta ’ fil- għodu; flimkien ma ’ skor VAS ta ’ ≥ 30 għal mill- inqas 2 minn dawn it- 3 parametri: assessjar globali tal- pazjent; valur medju tal- VAS għal uġigħ fid- dahar matul il- lejl u uġigħ totali fid - dahar; medja ta ’ 10 domandi fuq l- Indiċi Funzjonali ta ’ l- ankylosing spondylitis fil- Banju (BASFI).