qanastek/EMEA-V3 huggingface dataset:
au b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
methotrexate mgħotija flimkien bl- użu tat- test U Mann- Whitney. b. il- valur- p jiġi mit- tqabbil bejn pari ta ’ trattament b’ Trudexa waħdu u Trudexa u methotrexate mgħotija flimkien bl- użu tat- test U Mann- Whitney. c. ilvalur- p jiġi mit- tqabbil bejn pari ta ’ trattament b’ Trudexa waħdu u methotrexate waħdu bl - ott
r ge Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified total Sharp score ≤ 0.5) was significantly higher with lon Trudexa/ methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
(bidla mil- linja bażi fit- tibdil tal- puteġġ totali Sharp ≤ 0. 5) kien sinifikament ogħla bit- terapija kombinata ta ’ Trudexa/ methotrexate (63. 8% u 61. 2% rispettivament) meta pparagunat ma ’ kura b ’ methotrexate waħdu (37. 4% u 33. 5% rispettivament, p < 0. 001) u kura b’ Trudexa waħdu (50. 7%, Pr
Quality of life and physical function no
Kwalità ta ’ ħajja u funzjoni fiżika
All doses/ schedules of Trudexa t
Il- kwalità ta ’ ħajja relatata mas- saħħa u mal- funzjoni fiżika, li f’ ġimgħa 52 fi Studju III kienet skop primarju speċifikat minn qabel, ġiet stimata permezz ta ’ l- indiċi ta ’ diżabilità tal- kwestjunarju li
in all four studies showed statistically significantly greater improvement in the disability index of the uc
86 jassessja s- saħħa (HAQ) fl- erba ’ provi oriġinali adegwati u kontrollati ħafna li saru.
HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
Id- dożi/ modi differenti ta ’ kif jingħata kollha ta ’ Trudexa fl- erba’ studji, urew titjib, mil- linja bażi sa Xahar 6, fl - indiċi ta ’ diżabilità ta ’ l- HAQ, liema titjib hu sinifikament ikbar meta pparagunat mal- plaċebo, u fi Stuju II ġara l- isetss f’ ġimgħa 52.
Results from the Short Form Health Survey (SF 36) for all doses/ schedules of Trudexa in all four rod
Riżultati tal- istħarriġ tas- saħħa fil- forma il- qasira (SF 36) għad- dożi / modi differenti ta ’ kif jingħata kollha ta ’ Trudexa fl- erba ’ studji li huma, jikkonfermaw dan, b ’ punti li
studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
at huma statistikament sinifikanti fis- sommarju dwar il- komponent fiżiku (PCS), kif ukoll punti li huma statistikament sinifikanti fid- dominju ta ’ l- uġigħ u l- vitalità̀ għad- doża ta ’ 40 mg ġimgħa iva u ġimgħa
I, III, IV).
zz le.
In Study III, improvement in physical function was maintained through week 260 (60 months) of open-label treatment.
ori Fi Studju III, titjib fil- funzjoni fiżika ġie mantenut matul ġimgħa 260 (60 xahar) tal- kura open- label.
Improvement in quality of life was measured up to week 156 (36 months) and na
It- titjib fil- kwalità ta ’ ħajja ġie mkejjel sa ġimgħa 156 (36 xahar) u dan it- titjib ġie mantenut matul dan il- perjodu.
Me
t aw Fi Studju V, it- titjib fl- indiċi ta ’ diżabilità HAQ u fil- komponent fiżiku ta ’ l- SF 36 wera titjib akbar (p < 0. 001) għat- terapija kombinata ta ’ Trudexa/ methotrexate versu l- kura b’ methotrexate u l- kura b’ Trudexa waħdu f’ ġimgħa 52, liema titjib baqa ’ mantenut matul ġimgħa 104.
Psoriatic arthritis
ux Artrite Psorjatika
Trudexa, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, Studies VI and VII.
ad attiva minn moderata sa severa f’ żewġ studji kontrollati bil- plaċebo, Studji VI u VII.
Study VI with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
Studju VI li dam 24 ġimgħa, tratta 313 pazjent adult li kellhom rispons mhux adegwat għall- kura b’ mediċina anti - infjammatorja mhux sterojdi, u minn dawn, bejn wieħed u ieħor 50% kienu qegħdin jieħdu ’ g ħ methotrexate.
Study VII with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Studju VII li dam 12 - il ġimgħa, tratta 100 pazjent li kellhom rispons mhux adegwat għat- terapija DMARD.
79 There is insufficient evidence of the efficacy of Trudexa in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied (see Table 7).
f’ pazjenti li jbatu minn artrite psorjatika li tixbaħ lill- infjammazzjoni tal- vertebri li jirriżulta fil - vertebri jitwaħħlu flimkien (ankylosing spondylitis) (ara Tabella 7).
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Rispons għall- ACR fi Studji ta ’ l- Artrite Psorjatika kontrollati bil- Plaċebo li l
ed
(Persentaġġ ta ’ Pazjenti) ina
Placebo
Rispons
Trudexa Placebo
Plaċebo
ris Response
Humira
N=162
diċ
ACR 50
ACR 50 me
r *** p < 0.001 for all comparisons between Trudexa and placebo
*** p < 0. 001 għall- paraguni kollha bejn Humira u l plaċebo od
N/ A not applicable lon ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
Ir- risponsi għall- ACR fi Studju VI kienu simili kemm flimkien mal- kura b’ methotrexate, kif ukoll Pr
Trudexa treated patients demonstrated improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36), from base-line to week 24. no
Pazjenti kkurati b’ Trudexa urew titjib fil- funzjoni fiżika kif stimat bl- HAQ u l- istudju tas- saħħa fil - forma il- qasira (SF 36), mil- linja bażi sa ġimgħa 24.
Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double− blind, placebo− controlled studies in patients with active ankylosing spondylitis (mean t
87 It- teħid ta ’ 40 mg Trudexa ġimgħa iva u ġimgħa le kien stimat fi 393 pazjent f’ żewġ studji double - blind, kontrollati bil- plaċebo li ħadu 24 ġimgħa u li saru b’ ordni addoċċ fuq pazjenti li jbatu minn infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il- punt medju tal- linja bażi ta ’ l- attività tal- mard [l- Indiċi ta ’ l- Attività tal- Mard Ankylosing Spondylitis (BASDAI)] kien 6. 3 fil- gruppi kollha) li ma kellhomx rispons adegwata għat- terapija konvenzjonali.
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
at Disgħa u sebgħin (20. 1%) pazjent ġew ikkurati flimkien ma ’ mediċini anti- rewmatiċi li li jaffetwaw il - proċess tal- marda, u 37 (9. 4%) pazjent flimkien ma ’ glukokortikojdi.
The blinded period was followed by an open− label period rod
Il- perijodu blinded ġie segwit
during which patients received Trudexa 40 mg every other week subcutaneously for up to an additional 28 weeks.
zz b’ perijodu open- label, li matulu l- pazjenti rċevew 40 mg Trudexa taħt il- ġilda ġimgħa iva u ġimgħa le għal perijodu addizzjonali ta 28 ġimgħa. suġġetti (n = 215, 54. 7%) li ma laħqux l- ASAS 20 f’ ġimgħat 12, jew 16 jew 20 irċevew 40 mg adalimumab ħruġ kmieni open- label taħt il- ġilda ġimgħa iva u
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. lP
ori ġimgħa le, u kienu sussegwentament trattati bħala pazjenti li ma jirrispondux għal kura fl- analiżi ta ’ l - istatistika double - blind.
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo. na
t Fl- istudju ikbar (VIII) bi 315 pazjent, ir- riżultati urew titjib statistikament sinifikanti tas- sinjali u s -
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8).
Rispons sinifikanti ġie osservat l- ewwel f’ Ġimgħa 2 u nżamm tul 24 ġimgħa (Tabella 8).
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII i dic
ux Tabella 8 – Risponsi ta ’ l- Effikaċja fi Studju AS kontrollat bil- Plaċebo Effikaċja – Studju VIII Tnaqqis fisSinjali u s- Sintomi
Me
ad
Response
Rispons ASASa 20
ASASa 20
’ g ħ
Week 2 Week 12 Week 24
Ġimgħa 2 Ġimgħa 12 Ġimgħa 24
ASAS 50
ASAS 50 im
Week 2 Week 12
Ġimgħa 2
Week 24
Ġimgħa 12 Ġimgħa 24
ed BASDAIb 50
BASDAI 50
Week 2
Ġimgħa 2 diċ
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24
***, ** Statistikament sinifikanti f’ p < 0. 001, < 0. 01 għall- paraguni kollha bejn Trudexa u l - me
tho a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
plaċebo f’ Ġimgħa 2, 12 u 24 a Stima f ’ Ankylosing Spondylitis b Indiċi ta ’ l- Attività tal- Mard Bath Ankylosing Spondylitis
Trudexa treated patients had significantly greater improvement at Week 12 which was maintained
Pazjenti kkurati b’ Trudexa kellhom titjib akbar sinifikanti f’ Ġimgħa 12, li nżamm tul Ġimgħa 24 ott
au through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
kemm fl- SF36, kif ukoll fil- kwistjunarju dwar il- kwalità tal- ħajja Ankylosing Spondylitis (ASQoL).
Similar trends (not all statistically significant) were seen in the smaller randomised, double− blind,
Tendenzi simili (mhux kollha statistikament sinifikanti) ġew osservati fl- istudju iżgħar double- blind od
r placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
Pr
ge Crohn’ s Disease lon The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Is- sigurtà u l- effikaċja ta ’ Trudexa ġew stimati f ’’ il fuq minn 1400 pazjent li jbatu mill- marda Crohn (Crohn’ s disease) attiva b’ mod minn moderat sa sever (Indiċi ta ’ l- Attività tal- Marda Crohn (Crohn’ s disease) (CDAI) ≥ 220 u ≤ 450) fi studji double- blind, kontrollati bil- plaċebo, li saru b’ ordni addoċċ.
478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants) no
478 mill- pazjenti reġistrati (32%) ġew dikjarati bħala li jbatu minn marda severa (riżultat ta ’ CDAI
corresponding to the population defined in the indication (see section 4.1).
88 > 300 u t- teħid fl- istess waqt ta ’ corticosteroid u/ jew immunosoppressanti) li tikkorrespondi mal - popolazzjoni definite fl- indikazzjoni (ara sezzjoni 4. 1).
Concomitant stable doses of aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications. t
Dożi stabbli ta ’ aminosalicylates, corticosteroids, u/ jew aġenti immunomodulatorji mittieħda fl- istess waqt, kienu permessi u 79% tal - pazjenti komplew jirċievu mill- inqas waħda minn dawn il- mediċini.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and uc
at Il- qlib għall- aħjar fl- istat kliniku (definit bhala CDAI < 150) ġie evalwat f’ żewġ studji, CLASSIC I u GAIN.
In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
zz f’ wieħed minn erbgħa gruppi ta ’ nies li kienu qegħdin jieħdu l- kura; plaċebo f’ ġimgħat 0 u 2, 160 mg Trudexa f’ ġimgħa 0 u 80 mg f’ ġimgħa 2, 80 mg f’ ġimgħa 0 u 40 mg f’ ġimgħa 2, u 40 mg f’ ġimgħa 0 u 20 mg f’ ġimgħa 2.
In GAIN, 325 patients who had lost rod
F’ GAIN, 325 pazjent li ma kinux baqgħu juru rispons għall- kura jew li ma kinux
response or were intolerant to infliximab were randomised to receive either 160 mg Trudexa at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
ori jittolleraw infliximab kienu mqassma bl- addoċċ biex jirċievu jew 160 mg Trudexa f’ ġimgħa 0 u 80 mg f’ ġimgħa 2 jew plaċebo f’ ġimgħat 0 u 2.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. lP
Dawk il- pazjenti li ma wrewx rispons mill- ewwel ġew esklużi mill- istudji u għalhekk dawn il- pazjenti ma ġewx evalwati aktar.
Maintenance of clinical remission was evaluated in CHARM.
t aw Il- fatt jekk ġiex mantenut it- titjib kliniku ġie evalwat f’ CHARM.
Patients in clinical na
Pazjenti li kellhom rispons kliniku (tnaqqis f ’ CDAI ≥ 70) f’ ġimgħa 4 ġew
response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
ux isseparati minn ma ’ l- oħrajn u ġew analizzati separatement minn dawk li ma kellhomx rispons kliniku f’ ġimgħa 4.
Corticosteroid taper was permitted after week 8. i
It- tnaqqis tal- corticosteroid ftit ftit sakemm jitwaqqaf totalment, kien permess wara ġimgħa 8.
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9. dic Me
ad Ir- rati ta ’ kemm kien hemm qlib għall- aħjar fl- istat kliniku u r- rispons fi CLASSIC I u GAIN huma preżentati f’ Tabella 9. ’ g ħ Tabella 9:
Induction of Clinical Remission and Response (Percent of Patients)
Qlib għall- Aħjar fl- Istat Kliniku u Rispons (Persentaġġ ta ’ Pazjenti) im
Infliximab Naive Patients
Pazjenti li qatt ma ħadu infliximab Plaċebo Trudexa Trudexa N=74 80/ 40 mg 160/ 80 mg li l
Placebo Trudexa N=166 160/ 80 mg
Pazjenti li kienu diġà ħadu infliximab qabel Plaċebo Trudexa N=166 160/ 80 mg
tho 100) All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 **
Il- valuri- p kollha huma paraguni magħmula għal kull par ta ’ proporzjonijiet għal Trudexa kontra l - plaċebo * p < 0. 001 me
au p < 0.01
** p < 0. 01
Similar remission rates were observed for the 160/ 80 mg and 80/ 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/ 80 mg group.
Rati simili ta ’ titjib ġew osservati għad- dożaġġ tal- bidu ta’ 160/ 80 mg u 80/ 40 mg milħuqa sa ġimgħa 8 u fil- grupp tal- 160/ 80 mg, l- effetti avversi ġew innutati b’ mod aktar frekwenti. ott
Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
Minn dawk li kellhom rispons kliniku f’ ġimgħa 4, 48% kienu ġew esponuti għal kura oħra od
82 Trudexa 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at weeks 26 and 56 in CHARM as well among the adalimumab treatment groups compared to the placebo group.
(IBDQ), u dan f’ pazjenti li ġew magħżula bl- addoċċ u ngħataw 80/ 40 mg u 160/ 80 mg Trudexa meta mqabbel mal- plaċebo, u dan deher f’ ġimgħat 26 u 56 f’ CHARM, kif ukoll fil- gruppi tal- kura b’ adalimumab meta mqabbla mal- grupp tal- plaċebo. diċ
In patients not given concomitant methotrexate, the incidence was 16/ 185 (8.6%), compared to 1/ 19 (5.3%) when adalimumab was used as add-on to methotrexate. lon In patients with Crohn’ s disease, adalimumab antibodies were identified in 7/ 269 subjects (2.6%) treated with adalimumab.
90 F’ pazjenti li ma ngħatawx ukoll methotrexate flimkien ma ’ adalimumab, l- inċidenza kienet ta ’ 16/ 185 (8. 6%), meta pparagunat ma ’ 1/ 19 (5. 3%) meta adalimumab kien użat addizzjonalment ma ’ methotrexate.
83 levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Ġie osservat li l- livelli fis- serum ta ’ adalimumab ħieles (mhux imwaħħal ma anti- korpi ta ’ kontra adalimumab, AAA) kienu aktar baxxi f’ pazjenti b’ livelli AAA li jitkejlu. me
au 6.
91 6.
Trudexa 40 mg solution for injection in single-use pre-filled pen for patient use. dic
Trudexa 40 mg soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest li tintuża darba biss, għall- użu mill- pazjent: li l
Me
Pakketti ta ’: • Pinna waħda mimlija għal- lest, b’ kuxxinett wieħed bl- alkoħol f’ folja. ina
• 2 pre-filled pen, each with 1 alcohol pad, in a blister. • 4 pre-filled pen, each with 1 alcohol pad, in a blister. • 6 pre-filled pen, each with 1 alcohol pad, in a blister.
• 2 pinnen mimlijin għal- lest, b’ kuxxinett wieħed bl- alkoħol f’ folja kull wieħed. • 4 pinen mimlijin għal- lest, b’ kuxxinett wieħed bl- alkoħol f’ folja kull wieħed. • 6 pinen mimlijin għal- lest, b’ kuxxinett wieħed bl- alkoħol f’ folja kull wieħed. diċ
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema me
84 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali. ott
Abbott Laboratories Ltd.
Abbott Laboratories Ltd. od
ed Queenborough Kent ME11 5EL United Kingdom
Queenborough Kent ME11 5EL Renju Unit Pr
au EU/ 1/ 03/ 257/ 010
92 EU/ 1/ 03/ 257/ 008 EU/ 1/ 03/ 257/ 009 EU/ 1/ 03/ 257/ 010
9.
at 9.
r ge 1 September 2003 10.
zz 1 ta ’ Settembru 2003
uc rod lP i na dic Me
t aw ux ad ’ g ħ im li l ina diċ me ott od Pr
85 ed ris tho r au ge lon ANNEX II
93 at zz ori t aw ux ad ANNESS II ’ g ħ
MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR no
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA im
BATCH RELEASE
RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION t uc rod lP nai dic Me
GĦAT- TQEGĦID FIS- SUQ ina diċ me ott od Pr
86 A.
94 A.
MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
ed Abbott Bioresearch Center 100 Research Drive Worcester
at Abbott Bioresearch Center
ris MA 01605 USA
zz 100 Research Drive Worcester MA 01605
tho and
ori Stati Uniti ta ’ l- Amerika
Abbott Biotechnology Ltd.
t aw Abbott Biotechnology Ltd.
r Name and address of the manufacturer responsible for batch release
ux Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
ge Abbott Biotechnology Deutschland GmbH Max-Planck-Ring 2 lon D-65205 Wiesbaden Germany
ad Abbott Biotechnology Deutschland GmbH Max- Planck- Ring 2 D- 65205 Wiesbaden ’ g ħ Ġermanja
CONDITIONS OF THE MARKETING AUTHORISATION no
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ im
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER t uc
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - li l
Summary of Product Characteristics, section 4.2). rod
Prodott, sezzjoni 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI diċ
Not applicable. lP
Ma jgħoddx f’ dan il- każ. me
• OTHER CONDITIONS na
• KUNDIZZJONIJIET OĦRA
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan. i
Il- MAH tikkommetti ruħha sabiex twettaq l- studji u l- attivitajiet farmakoviġilanti addizzjonali li jinsabu imniżżla fil- pjan tal- famakoviġilanza. ott
An updated risk management plan should be provided as per the CHMP guideline on the risk dic
Għandu jiġi provdut pjan aġġornat dwar l- immaniġjar tar- riskju, u dan skond il- linja gwida CHMP li titratta dwar is- sistemi ta ’ l- immaniġjar tar- riskju għall- prodotti mediċinali magħmula għall- użu mill- bniedem. od
management systems for medicinal products for human use.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu Pr
Me
jippreżenta kull 6 xhur rapporti li jikkonsistu f’ aġġornament dwar is- sigurtà tal- mediċina.
LABELLING AND PACKAGE LEAFLET t no uc rod lP nai dic Me
95 at zz ori t aw ux ad ANNESS III ’ g ħ TIKKETTA U FULJETT TA ’ TAGĦRIF im li l ina diċ me ott od Pr
88 Me dic ina lP rod uc t
96 Pr od ott me diċ ina
89 no A.
97 li l im A.
LABELLING lon ge PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA ’ g ħ ad ux aw TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ed Trudexa 40 mg solution for injection Adalimumab
zz Trudexa 40 mg soluzzjoni għall- injezzjoni Adalimumab
One 0.8 ml vial contains 40 mg adalimumab
t aw Kunjett wieħed ta ’ 0. 8 mg adalimumab
Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate
ux Sustanzi mhux attivi: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma
ge water for injections.
ad għall- injezzjonijiet.
See leaflet for further information. lon 4.
Ara l- fuljett għal aktar informazzjoni. ’ g ħ 4.
1 vial containing 40 mg adalimumab 1 sterile injection syringe with fixed needle no
Kunjett wieħed fih 40 mg adalimumab im
2 alcohol pads
Siringa sterili għall- injezzjoni bil- labra mwaħħla 2 kuxxinetti bl- alkoħol li l
METHOD AND ROUTE(S) OF ADMINISTRATION t uc
MOD TA ’ KIF U MNEJN JINGĦATA
Subcutaneous use.
Użu għal taħt il- ġilda. ina
Read the package leaflet before use. rod
Aqra l- fuljett ta ’ tagħrif qabel l- użu. diċ
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN lP
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL me
Keep out of the reach and sight of children. na
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
OTHER SPECIAL WARNING(S), IF NECESSARY i dic
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA ott
EXP {MM/ YYYY} Me
JIS {XX/ SSSS} Pr
Keep the vial in the outer carton.
Żomm il- kunjett fil- kartuna ta ’ barra..
90 10.
98 10.
ris Kent ME11 5EL United Kingdom
ori Queenborough Kent ME11 5EL Renju Unit
tho 12.
t aw 12.
13.
ux 13.
r ge LOT: lon 14.
ad LOTT: ’ g ħ 14.
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA im
Medicinal product subject to medical prescription. no
Prodott mediċinali jingħata bir- riċetta tat- tabib.
INSTRUCTIONS ON USE t
STRUZZJONIJIET DWAR L- UŻU li l ina
INFORMATION IN BRAILLE uc
INFORMAZZJONI BIL- BRAILLE
Trudexa 40 mg rod lP i na dic Me
Trudexa 40 mg diċ me ott od Pr
91 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
ris Store in a refrigerator.
ori Aħżen fi friġġ.
tho 2.
t aw 2.
3.
ux 3.
r ge EXP {MM/ YYYY} 4.
ad JIS {XX/ SSSS} ’ g ħ 4.
OTHER t uc rod lP Me
OĦRAJN li l ina diċ me ott od Pr
92 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
100 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ed Trudexa 40 mg injection Subcutaneous use
zz Trudexa 40 mg injezzjoni Użu għal taħt il- ġilda
r 4.
ux 4.
LOT: ge lon 5.
ad LOTT: ’ g ħ 5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI im
40 mg/ 0.8 ml no
40 mg/ 0. 8 ml
OTHER t uc rod lP i na dic Me
OĦRAJN li l ina diċ me ott od Pr
ed Trudexa 40 mg solution for injection in pre-filled syringe Adalimumab
zz Trudexa 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Adalimumab
One 0.8 ml pre-filled syringe contains 40 mg adalimumab
t aw Siringa waħda ta ’ 0. 8 ml mimlija għal- lest fiha 40 mg adalimumab
1 pre-filled syringe containing 40 mg adalimumab 1 alcohol pad no
Siringa waħda mimlija għal- lest li fiha 40 mg adalimumab im
METHOD AND ROUTE(S) OF ADMINISTRATION t
MOD TA ’ KIF U MNEJN JINGĦATA li l
Subcutaneous use uc
Użu għal taħt il- ġilda. ina
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN lP
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children. na
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. me
2 pre-filled syringes, each containing 40 mg adalimumab 2 alcohol pads no
2 kuxxinetti bl- alkoħol
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
105 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
4 pre-filled syringes, each containing 40 mg adalimumab 4 alcohol pads no
4 kuxxinetti bl- alkoħol
Do not freeze.
Żomm is- siringa fil- kartuna ta ’ barra Tagħmlux fil- friża.
98 10.
106 10.
99 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
6 pre-filled syringes, each containing 40 mg adalimumab 6 alcohol pads no
6 siringi mimlijin għal- lest, li fihom 40 mg adalimumab kull waħda im
100 10.
108 10.
101 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
102 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
110 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ed Trudexa 40 mg injection
zz Trudexa 40 mg injezzjoni
ris Subcutaneous use
ori Użu għal taħt il- ġilda
tho 2.
t 2.
EXP {MM/ YYYY}
ux JIS {XX/ SSSS}
r ge 4.
ad 4.
LOT: lon 5.
LOTT: ’ g ħ 5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT no
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI im
40 mg/ 0.8 ml
40 mg/ 0. 8 ml li l
OTHER t uc rod lP i na dic Me
OĦRAJN ina diċ me ott od Pr
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA, JEW FEJN M’ HEMMX PAKKETT TA ’ BARRA, FUQ IL- PAKKETT EWLIENI
ed 1.
at zz 1.
ris Adalimumab
ori Adalimumab
One 0.8 ml pre-filled syringe with needleguard contains 40 mg adalimumab
aw Siringa waħda ta ’ 0. 8 ml mimlija għal- lest bil- labra mgħottija fiha 40 mg adalimumab
au 3.
ux 3.
r Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate
Sustanzi mhux attivi: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate
ge dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
ad dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjonijiet.
PHARMACEUTICAL FORM AND CONTENTS
GĦAMLA FARMAĊEWTIKA U KONTENUT im
1 pre-filled syringe containing 40 mg adalimumab no
Siringa waħda mimlija għal- lest li fiha 40 mg adalimumab Kuxxinett wieħed bl- alkoħol li l
METHOD AND ROUTE(S) OF ADMINISTRATION t uc
MOD TA ’ KIF U MNEJN JINGĦATA ina
ed Trudexa 40 mg solution for injection in pre-filled syringe with needleguard Adalimumab
zz Trudexa 40 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest bil- labra mgħottija Adalimumab
106 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
107 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ed Trudexa 40 mg solution for injection in pre-filled pen Adalimumab
zz Trudexa 40 mg soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest Adalimumab
One 0.8 ml pre-filled pen contains 40 mg adalimumab
t aw Pinna waħda ta ’ 0. 8 ml mimlija għal- lest fiha 40 mg adalimumab
1 pre-filled pen, containing 40 mg adalimumab 1 alcohol pad no
Pinna waħda mimlija għal- lest, li fiha 40 mg adalimumab im
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
2 pre-filled pens, each containing 40 mg adalimumab 2 alcohol pads no
2 pinen mimlijin għal- lest, li fiha 40 mg adalimumab kull waħda im
Read the package leaflet before use. rod
Aqra l- fuljett ta ’ tagħrif qabel l- użu diċ
4 pre-filled pens, each containing 40 mg adalimumab 4 alcohol pads no
4 pinen mimlijin għal- lest, li fiha 40 mg adalimumab kull waħda im
6 pre-filled pens, each containing 40 mg adalimumab 6 alcohol pads no
6 pinen mimlijin għal- lest, li fiha 40 mg adalimumab kull waħda im
r LOT:
ad LOTT: ’ g ħ 14.
GENERAL CLASSIFICATION FOR SUPPLY ge lon Medicinal product subject to medical prescription. no
Prodott mediċinali jingħata bir- riċetta tat- tabib.
INSTRUCTIONS ON USE
STRUZZJONIJIET DWAR L- UŻU li l ina
INFORMATION IN BRAILLE t uc
INFORMAZZJONI BIL- BRAILLE
116 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
124 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PEN LABEL
TIKKETTA TAL- PINNA
117 REMINDER STICKERS TEXT (included in pack)
125 KITBA TA ’ TFAKKIR LI TWAĦĦAL FUQ IT- TIKETTA (inkluża fil- pakkett)
Trudexa
at Trudexa
Mark your calendar with the stickers provided to remind you of the date for your next dose.
zz Immarka il- kalendarju bit- tiketti li twaħħal provduti biex iffakruk fid- data ta ’ meta għandek tieħu d - doża li jmiss.
ed ris tho
ori t aw ux ad ’ g ħ im li l ina diċ me ott od Pr
lon
126 KITBA FUQ IL- KARTUNA TA ’ TWISSIJA GĦAL- PAZJENT (MHUX INKLUŻA FIL - PAKKETT JEW BĦALA PARTI MILL- FULJETT TA ’ TAGĦRIF)
ge
at Kartuna ta ’ twissija għal- pazjent fuq Trudexa
r
Insuffiċjenza tal- qalb
au
zz Din il- kartuna ta ’ twissija fiha informazzjoni importanti dwar is- sigurtà, li inti għandek tkun taf biha qabel ma tingħata u waqt il- kura b’ Trudexa.
lP
Qabel il- kura b’ Trudexa: • Trudexa m’ għandux jintuża jekk int tbati minn insuffiċjenza tal- qalb minn moderata
rod
ori sa severa. • Uri din il- kartuna lil kwalunkwe tabib
uc
involut fil- kura tiegħek.
t
Waqt il- kura b’ Trudexa:
no
t aw Infezzjonijiet
dic
•
118 PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE PACKAGE LEAFLET)
Jekk tiżviluppa sintomi ta ’ insuffiċjenza tal- qalb (qtugħ ta ’ nifs jew nefħa fis - saqajn), irrikorri għall- għajnuna medika
Trudexa Patient Alert Card
Trudexa jżid ir- riskju illi inti tieħu infezzjonijiet.
Heart Failure
immedjatament.
ed This alert card contains important safety information that you need to be aware of before you are given Trudexa and during treatment with
ux jkunu
Prior to Trudexa treatment: • Trudexa should not be used if you have moderate to severe heart failure.
Dan jinkludi t- tuberkulosi.
During Trudexa treatment:
Dati tal- kura b’ Trudexa:
tho •
Qabel
Show this card to any doctor involved in your treatment.
il- kura b’ Trudexa:
• If you develop symptoms of heart failure (shortness of breath or swelling of the feet) seek medical attention immediately.
L- injezzjonijiet ta ’ wara:
Trudexa increases the risk of getting infections.
Int m’ għandekx tingħata kura b’ Trudexa jekk għandek infezzjoni severa.
1 st injection: _______________________ Following injections: _______________________
_______________________ _______________________ _______________________
ge Prior to Trudexa treatment: • You should not be treated with Trudexa if you have a severe infection.
Huwa importanti ħafna li int tgħid lit- tabib tiegħek jekk inti kellek xi darba t - tuberkulosi, jew jekk kellek kuntatt mill - im
_______________________ _______________________
_______________________ • Ara l- fuljett ta ’ tagħrif ta ’ Trudexa għal
• You should be screened for tuberculosis.
aktar informazzjoni.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has no
jogħġbok, hawn taħt niżżel id- dati ta ’ meta inti ġejt ittestjat l- aħħar għat- tuberkulosi:
• See the Trudexa package leaflet for more information. • Please make sure you also have a list of all your other medicines with you at any visit to
Jekk jogħġbok kun żgur li jkollok lista tal - mediċini l- oħra kollha li inti qiegħed tieħu
had tuberculosis.
Test tat- tuberkolina: _______________
Please record the dates of the last screening for tuberculosis below:
meta tmur għand professjonist tas- saħħa.
a health care professional.
X- ray tas- sider:
Tuberculin test: _______________ Chest X-ray: _______________ t
_______________
Doctor’ s Phone: _____________________ uc
Isem il- pazjent: _____________________
During Trudexa treatment:
Waqt il- kura b’ Trudexa: ina
• If you develop symptoms suggestive of •
Isem it- tabib: _____________________ • In- numru tat- telefon tat- tabib: __________ Jekk inti tiżviluppa sintomi li huma tipiċi għall- infezzjonijiet, bħal deni, sogħla
Keep this card with you for 5 months after the
persistenti, tnaqqis fil- piż, jew nuqqas ta ’ diċ
infections, such as fever, persistent cough, rod
•
last Trudexa dose, since side effects may
Żomm din il- kartuna fuqek għal 5 xhur
weight loss, or listlessness, seek medical attention immediately. lP i na dic
kwiet fil- ġisem, irrikorri għall- għajnuna medika immedjatament. me ott
occur a long time after your last dose of Trudexa.
wara li tkun ħadt l- aħħar doża ta’ Trudexa, minħabba li l- effetti mhux mixtieqa jistgħu jirriżultaw żmien twil wara l- aħħar doża ta ’ Trudexa.
119 Me dic ina lP rod uc t
127 Pr od ott me diċ ina
120 no B.
128 li l im ’ g ħ B.
PACKAGE LEAFLET lon ge
FULJETT TA ’ TAGĦRIF ad ux aw FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
Trudexa 40 mg soluzzjoni għall- injezzjoni f’ kunjetti Adalimumab
Trudexa 40 mg solution for injection in vials Adalimumab
at Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina.
ed Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Jista ’ jkollok bżonn terġa ’ taqrah.
You may need to read it again. − Your doctor will also give you a Patient Alert Card, which contains important safety
- It- tabib tiegħek se jagħtik ukoll Kartuna ta ’ Twissija tal- Pazjent, li fiha informazzjoni importanti
ris information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
dwar is- sigurtà, li inti għandek tkun taf biha qabel tingħata Trudexa u waqt il- kura b’ Trudexa.
Keep this Patient Alert Card together with the package leaflet. − If you have any further questions, please ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
tho − This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
au please tell your doctor or pharmacist.
aw imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Trudexa is and what it is used for
X’ inhu Trudexa u għalxiex jintuża
r 2.
ux 2.
ge 3.
Qabel ma tuża Trudexa 3.
How to use Trudexa 4.
Kif għandek tuża Trudexa 4.
Possible side effects 5 How to store Trudexa lon 6.
Kif taħżen Trudexa 6.
Further information
Aktar tagħrif ’ g ħ 1.
WHAT TRUDEXA IS AND WHAT IT IS USED FOR no
X’ INHU TRUDEXA U GĦALXIEX JINTUŻA
Trudexa is intended for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Trudexa huwa intenzjonat għall- kura ta ’ l- artrite rewmatika, artrite psorjatika u infjammazzjoni tal - im
It is a medicine that decreases the inflammation process of these diseases.
Hija mediċina li tnaqqas il - proċess ta ’ infjammazzjoni ta ’ dan il- mard.
Monoclonal antibodies are t
L- anti- korpi monoklonali huma proteini li jagħrfu lil u li l
proteins that recognise and bind to other unique proteins.
jeħlu ma ’ proteini uniċi oħra.
(tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. rod
Adalimumab jeħel ma ’ proteina speċifika (fattur tan- nekrosi tat- tumur jew TNFα), li tinsab f’ livelli aktar għolja f’ mard infjammatorju bħal artrite rewmatika, artrite psorjatika u infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing ina
Rheumatoid arthritis
Artrite rewmatika diċ
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. lP
Jekk inti tbati minn artrite rewmatika attiva li hi minn moderata sa severa, tista ’ għall- ewwel tingħata medicini oħra li jaffetwaw il- proċess tal- mard, bħal methotrexate.
If you do not respond well enough to these medicines, you will be given Trudexa to treat your rheumatoid arthritis. na
Jekk ma tirrispondix tajjeb biżżejjed ghal dawn il- mediċini, inti tingħata Trudexa me
Trudexa can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. i
għall- kura ta ’ l- artrite rewmatika.
Trudexa has been shown to slow down the damage to the cartilage and bone of the joints caused by the dic
Trudexa jista ’ ukoll jintuża għall- kura ta ’ l- artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat kura b’ methotrexate qabel. ott
disease and to improve physical function.
Ġie ppruvat li Trudexa jittardja l- ħsara fuq il- qarquċa u fuq l- għadam tal- ġogi, li tiġi kkawżata mill - marda, u li jtejjeb il- funzjoni fiżika. od
Usually, Trudexa is used with methotrexate.
Ġeneralment, Trudexa jintuża ma ’ methotrexate.
121 Ankylosing spondylitis
129 Infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
If you have ankylosing spondylitis you will first be given other medicines.
Jekk ma tirrispondix
If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
at tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Trudexa biex tnaqqas is- sinjali u s- sintomi tal - marda tiegħek.
ed Crohn’ s disease
zz Il- marda Crohn (Crohn’ s disease)
ris Crohn’ s disease is an inflammatory disease of the digestive tract.
ori Il- marda Crohn (Crohn’ s disease) hija marda infjammatorja tal- parti tal- ġisem minn fejn jgħaddi l - ikel.
If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
Jekk ma jkollokx rispons tajjeb biżżejjed għal dawn il- mediċini, inti tingħata Trudexa biex tnaqqas is- sinjali u
tho 2.
aw 2.
BEFORE YOU USE TRUDEXA
QABEL MA TUŻA TRUDEXA
au Do not use Trudexa:
ux Tużax Trudexa
• If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal adalimumab jew sustanzi oħra ta ’
ge Trudexa”).
ad Trudexa.
It is important that you tell your doctor if you have symptoms of infections, e. g. fever, wounds, feeling tired, dental problems. lon • If you have moderate or severe heart failure.
Huwa importanti li inti tgħid lit- tabib tiegħek jekk għandek sintomi ta ’ infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas- snien.
It is important to tell your doctor if you have had or have a serious heart condition (see “ Take special care with Trudexa”).
tabib tiegħek jekk inti kellek jew għandek xi kundizzjoni serja tal- qalb (ara “ Oqgħod attent ħafna b’ Trudexa ”). li l
Take special care with Trudexa: no
Oqgħod attent ħafna b’ Trudexa
• If you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Trudexa and contact your doctor immediately. t
• Jekk inti tesperjenza reazzjonijiet allerġiċi bħal għafis fis- sider, tħarħir, sturdament, nefħa jew ina
• uc
raxx, tinjettax aktar Trudexa, u kkuntatja lit- tabib tiegħek immedjatament.
The needle cover of the syringe contains natural rubber (latex).
• L- għatu tal- labra tas- siringa fih lastku naturali (latex).
This may cause severe allergic reactions in patients sensitive to latex.
Dan jista ’ jikkaġuna reazzjonijiet allerġiċi diċ
Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield. rod
Pazjenti li jafu li għandhom sensittività għal- latex għandhom ikunu avżati biex jevitaw li jmissu l- għatu ta ’ ġewwa.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa.
• Jekk għandek infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata (per eżempju, ulċera fir- riġel) me
If you are unsure, please contact your doctor. lP
kellem lit- tabib tiegħek qabel tibda Trudexa.
• You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare cases, be life-threatening.
• Jista ’ jkun li waqt li tkun qiegħed tirċievi l- kura b’ Trudexa, jaqbduk infezzjonijiet aktar ott
feeling tired or dental problems.
faċilment, inkluż infezzjonijiet serji, tuberkulosi, infezzjonijiet opportunistiċi u sepsis li, f’ każi rari, jistgħu ipoġġu l- ħajja fil- periklu.
• As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will i
Huwa importanti li inti tgħid lit- tabib tiegħek jekk ikollok sintomi bħal deni, feriti, tħossok għajjien jew ikollok problemi tas- snien. od
check you for signs and symptoms of tuberculosis before starting Trudexa.
• Peress illi ġew irrappurtati każi ta ’ tuberkulosi f’ pazjenti kkurati b’ Trudexa, qabel tibda Trudexa, it- tabib tiegħek se jeżaminak għal sinjali u sintomi tat- tuberkulosi.
This will include a dic
Dan jinkludi storja Pr
thorough medical history, a chest X-ray and a tuberculin test.
medika fid- dettal, X- ray tas- sider u test tat- tuberkolina. It- twettiq ta ’ dawn it- testijiet għandu jiġi mniżżel fuq il- Kartuna ta ’ Twissija tal- Pazjent.
The conduct of these tests should be recorded on your Patient Alert Card.
Huwa importanti ħafna li inti tgħid lit- tabib tiegħek jekk inti kellek xi darba t- tuberkulosi, jew jekk kellek kuntatt mill- qrib ma ’ xi ħadd li kellu t- tuberkulosi.
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had Me
Jekk jitfaċċaw sintomi tat- tuberkulosi (sogħla persistenti, tnaqqis fil- piż, nuqqas ta ’ kwiet fil- ġisem, deni ħafif), jew titfaċċa xi infezzjoni oħra waqt jew wara t- terapija, għid lit- tabib tiegħek immedjatament.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
130 • Għarraf lit- tabib tiegħek f’ każ illi inti għandek storja medika ta ’ infezzjonijiet li jaqbduk minn żmien għal żmien, jew kundizzjonijiet oħra li jżidu r- riskju ta ’ infezzjonijiet.
• Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
• Jekk int iġġorr il- virus ta ’ l- epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li
• Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
at għandek riskju li jaqbdek l- HBV, għarraf lit- tabib tiegħek.
Trudexa can cause reactivation of 122 HBV in people who carry this virus.
Trudexa jista ’ jikkaġuna riattivazzjoni ta ’ HBV f’ pazjenti li jġorru dan il- virus.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
zz qiegħed tieħu mediċini oħra li jrażżnu s- sistema immuni, ir- riattivazzjoni ta ’ l- HBV tista ’ tpoġġilek ħajtek fil- periklu.
• If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.
ori • Jekk inti se tagħmel xi operazzjoni jew se tgħamel xi intervent tas- snien, jekk jogħġbok għarraf lit- tabib tiegħek li inti qiegħed tieħu Trudexa.
ed • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.
t • Jekk inti tbati minn sklerosi multipla, it- tabib tiegħek għandu jiddeċiedi jekk inti għandekx
• Some vaccines should not be given while receiving Trudexa.
aw tirċievi Trudexa.
ris before you receive any vaccines.
Jekk jogħġbok iċċekkja mat- tabib tiegħek qabel ma tieħu xi tilqim.
• If you have mild heart failure and you are being treated with Trudexa, your heart failure status
Huwa importanti illi
It is important to tell your doctor if you have had or have a serious heart condition.
ad inti tgħid lit- tabib tiegħek jekk inti kellek jew għandek xi kundizzjoni serja tal- qalb.
If you develop new or worsening symptoms of heart failure (e. g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Jekk tiżviluppa deni li ma im
Your doctor may
jgħaddilekx, jew tibda titbenġel faċilment jew joħroġlok id- demm faċilment, jew tkun pallidu ħafna, ċempel lit- tabib tiegħek immedjatament.
r decide to stop treatment.
It- tabib tiegħek jista ’ jiddeċiedi li jwaqqaf il - kura. li l
ge • There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other TNF blockers.
• Kien hemm każi rari ħafna ta ’ ċerti tipi ta ’ kanċer f’ pazjenti li jieħdu Trudexa jew mediċini oħra li jimblukkaw t- TNF.
People with more serious rheumatoid arthritis that have had the disease for a lon long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma.
Persuni li għandhom artrite rewmatika aktar serja u li ilhom ibatu minnha għal żmien twil jista ’ jkollhom riskju akbar mill- medja li jaqbadhom kanċer li jaffetwa is - ina
If you take Trudexa your risk may increase.
Jekk tieħu Trudexa, ir- riskju jista ’ jiżdied.
In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa. no
Barra minn hekk, f’ pazjenti li jieħdu Trudexa, ġew osservati każi rari ħafna ta ’ kanċer tal- ġilda mhux tat- tip melonoma. diċ
• Cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Jekk inti tbati minn COPD, jew tpejjep me
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you. t uc
ħafna, inti għandek tiddiskuti mat- tabib tiegħek fuq jekk il- kura b’ mediċina li timblokka t- TNF hijiex adattata għalik.
Using other medicines
Meta tuża mediċini oħra ott
Trudexa can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents rod
Trudexa jista ’ jittieħed flimkien ma ’ methotrexate jew ċerti tipi ta ’ aġenti anti- rewmatiċi li jaffetwaw il- proċess tal- mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad- deheb li od
(sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs.
Pr
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, lP
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you have na
M’ għandekx tieħu Trudexa ma ’ mediċini li fihom is- sustanza attiva anakinra.
questions, please ask your doctor.
Jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi lit- tabib tiegħek.
Using Trudexa with food and drink i dic
131 Meta tuża Trudexa ma ’ l- ikel u max- xorb.
Since Trudexa is given subcutaneously, food and drink should not affect Trudexa.
Peress li Trudexa jingħata taħt il- ġilda, l- ikel u x- xorb m’ għandhomx jaffetwawh.
Pregnancy and breast-feeding Me
Tqala u Treddigħ
The effects of Trudexa in pregnant women are not known and so the use of Trudexa in pregnant women is not recommended.
at L- effetti ta ’ Trudexa fuq nisa tqal għadhom m’ humiex maghrufa, u għalhekk l- użu ta ’ Trudexa min -
You are advised to avoid becoming pregnant and must use adequate contraception while using Trudexa and for at least 5 months after the last Trudexa treatment.
Inti għandek tevita li tinqabad tqila u għandek tuża mezz ta ’ kontraċezzjoni adegwat waqt li tkun qiegħda tuża Trudexa u għal mill- inqas 5 xhur wara l- aħħar trattament b’ Trudexa.
It is not known whether adalimumab passes into breast milk.
ori M’ huwiex magħruf jekk adalimumab jgħaddix fil- ħalib tas- sider.
123 If you are a breast-feeding mother, you should stop breast-feeding during Trudexa treatment and for at least 5 months after the last Trudexa treatment.
t Jekk inti qiegħda tredda ’, int għandek tieqaf tredda ’ matul it- trattamant b’ Trudexa u għal mill- inqas 5
Trudexa should not affect your ability to drive or use machinery.
ux Trudexa m’ għandux jaffetwa l- abilità tiegħek li ssuq jew tħaddem magni.