qanastek/EMEA-V3 huggingface dataset:
If the production of red blood cells is reduced you may have symptoms of tiredness or
Jekk tonqoslok il- produzzjoni ta 'ċelluli tad- demm ħomor jista' jkollok sintomi ta 'għeja u nuqqas ta' nifs.
41 breathlessness.
nuqqas ta ’ rqad, uġigħ fil- ġogi, disturbi fil- muskoli
A reduction in your white blood cell count can make you more prone to infection.
- nuqqas ta ’ aptit, rimettar, uġigħ fl- istonku u bugħawwieġ, dijarea
Increase in enzymes produced by the liver. − tiredness, high temperature, dizziness, malaise, general feeling of being unwell, lethargy, difficulty in sleeping, joint pain, muscle disorders. − cough, nasal symptoms, (irritation, runny nose). − loss of appetite, vomiting, stomach pain and cramps, diarrhoea, − abacavir hypersensitivity, skin rash (without any other illness), hair loss.
- sensitivita ’ eċċessiva għal abacavir, raxx (mingħajr disturbi ieħor), jaqa ’ x- xagħar.
Uncommon side effects (reported in 1 to 10 out of 1000 patients)
Effetti sekondarji mhux komuni (rrapurtati f’ 1 sa 10 minn kull 1000 pazjent)
− Reduction in platelets (blood cells important for blood clotting) has been reported.
Jekk
If you have a low platelet count you may notice that you bruise more easily. − Breathlessness, flatulence, itching.
ikollok l- għadd ta ’ pjastrini baxx għandek mnejn tosserva li qed titbenġel malajr.
Rare side effects (reported in less than 1 in 1000 patients)
Effetti sekondarji rari (rrapurtati f’ anqas min 1 kull 1000 pazjent)
− anxiety, depression, drowsiness, convulsions (fits). − taste changes, patchy colour changes in the mouth, indigestion, inflammation of the pancreas, liver disorders such as enlarged liver, fatty liver, jaundice and inflammation (hepatitis), increase in an enzyme called amylase. − urinary frequency, enlargement of the breasts in men, chest pain may occur, possibly indicating a heart muscle disease called cardiomyopathy. numbness, tingling sensation or sensation of weakness in the limbs, breakdown of muscle tissue. − nail and skin colour changes, sweating, chills, flu-like symptoms.
tal- pankreas, disturbi fil- fwied fosthom fwied kbir, fwied bix- xaħam, suffejra, u infjammazzjoni (epatite), żieda fl- enżima amylase.
Very rare side effects (reported in less than 1 in 10, 000 patients)
Effetti sekondarji rari ħafna (rrapurtati f’ anqas min 1 f’ 10, 000 pazjent)
− serious skin reactions, severe anaemia and neutropenia.
- reazzjonijiet serji fil- ġilda, anemija severa u newtropenjia
Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body have been reported in some patients taking NRTIs (see “ Take special care with Trizivir” under section 2 for use for more information).
Każijiet ta 'kondizzjoni magħrufa bħala aċidożi lattika, li hi tiġmigħ ta' aċidu lattiku fil- ġisem, ġew rappurtati f' xi ftit pazjenti li kienu jieħdu NRTIs (ara ” Oqgħod attent ħafna b’ Trizivir f’ taqsima 2 għal aktar tagħrif).
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija antiretrovirali kombinata tista ġġib bidliet fl- għamla tal- ġisem minħabba t- tibdil fid - distribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump ').
Dawn jistgħu jinkludu tnaqqis ta 'xaħam fis- saqajn, fid- dirgħajn u l- wiċċ, żieda ta' xaħam fiż- żaqq u organi interni oħra, tkabbir tas- sider u għoqod tax- xaħam wara l- għonq ('buffalo hump').
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul fuq is- saħħa ta 'dawn il- kondizzjonijiet s' issa għad mhumiex magħrufa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija antiretrovirali kombinata tista 'wkoll tikkawża żieda ta' l- aċidu lattiku u zokkor fid- demm, iperlipemja (żieda ta 'xaħam fid- demm) u reżistenza għall- insulina.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew spiżjar tiegħek.
HOW TO STORE TRIZIVIR
KIF TAĦŻEN TRIZIVIR
Do not store above 30°C.
Taħżinx f' temperatura ’ l fuq minn 300C.
Do not use Trizivir after the expiry date which is stated on the packaging.
Tużax Trizivir wara d- data ta 'l- iskadenza li tidher fuq il- kontenitur.
What Trizivir contains The active substances in each Trizivir film-coated tablet are 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
X’ fih Trizivir: is- sustanzi attivi f’ kull pillola ta ’ Trizivir miksija b’ rita huma 300mg ta ’ abacavir (bħala sulfate), 150mg ta ’ lamivudine u 300mg ta ’ zidovudine.
The other ingredients are microcrystalline cellulose, sodium starch glycollate and magnesium stearate in the core of the tablet.
Is- sustanzi l- oħra huma microcrystalline cellulose, sodium starch glycollate u magnesium stearate fil - qalba tal- pillola.
The tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
Ir- rita tal- pillola fiha hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
What Trizivir looks like and contents of the pack The capsule-shaped film-coated tablets are blue/ green and engraved with ‘ GX LL1’ on one side.
Il- pilloli miksijin b' rita u f' għamla ta 'kapsula huma ta' lewn blu/ aħdar inċiżi bil- karattri 'GX LLI' fuq naħa waħda.
They are provided in blister packs containing 60 tablets or bottles containing 60 tablets with child-resistant tops.
Ikunu ġo folji f' pakketti ta '40 jew 60 pillola jew fi fliexken li ma jistgħux jinfetħu mit - tfal u li jkun fihom 60 pillola.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom
Glaxo Group Ltd, Greenford Road, Greenford, Middlesex UB6 0NN, Ir- Renju Unit.
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, UK
Manifattur: Glaxo Operations UK Ltd., (trading as Glaxo Wellcome Operations), Priory Street, Ware, Herts SG12 0DJ, UK
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Danmark GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00 info@glaxosmithkline. dk
43 Danmark GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00 info@ glaxosmithkline. dk
Tel: + 421 (0)2 49 10 33 11 recepcia. sk@gsk. com
Dan il- fuljett kien approvat l- aħħar f ’
TRUDEXA
zz TRUDEXA
tho This document is a summary of the European Public Assessment Report (EPAR).
t aw Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
ux Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
r of the EPAR).
ad X’ inhu Trudexa?
What is Trudexa? ge lon Trudexa is a medicine containing the active substance adalimumab.
Trudexa hu mediċina li fiha s- sustanza attiva adalimunab.
It is available as a solution for injection in a vial, pre-filled syringe or pre-filled pen, all containing 40 mg of adalimumab.
Jiġi bħala soluzzjoni għall- injezzjoni ’ g ħ f’ kunjetti, siringa mimlija għal- lest jew pinna mimlija għal- lest, li kollha kemm huma jkun fihom 40 mg ta ’ adalimumab. im
What is Trudexa used for? no
Għal xiex jintuża Trudexa?
Trudexa is an anti-inflammatory medicine.
Trudexa hu prodott mediċinali anti- inflammatorju.
It is used to treat adults with the following diseases: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Jintuża fl- adulti għat- trattament ta ’ dawn il - mardiet: • artrite rewmatika (marda tas- sistema immunoloġika li tikkawża infjammazzjoni tal- ġogi). li l
Trudexa is used in combination with methotrexate (a medicine that acts on the immune system) in patients with moderate or severe disease who have not responded adequately to other t
Trudexa jintuża flimkien ma ’ methotrexate (mediċina li taħdem fuq is- sistema immunoloġika) f’ pazjenti b’ mard moderat jew sever li ma jkunux wieġbu b’ mod adegwat għal trattamenti ina
Trudexa uc
oħra, jew f’ pazjenti b’ mard sever li ma jkunux ħadu methotrexate qabel.
can be used alone if the patient cannot take methotrexate. • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) in patients who have not responded adequately to other treatments, rod
Trudexa jista ’ jintuża waħdu jekk il- pazjent ma jkunx jista ’ jieħu methotrexate • artrite psorjatika (marda li tikkawża rqajja ’ ħomor, bil- qxur fuq il- ġilda u infjammazzjoni tal - ġogi) f’ pazjenti li ma jkunux wieġbu b’ mod adegwat għal trattamenti oħra, diċ
• severe ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) in patients who have not responded adequately to other treatments.
• spondilite ankilotika (marda li tikkawża infjammazzjoni u uġigħ fil- ġogi tas- sinsla tad- dahar) f’ pazjenti li ma jkunux wieġbu b’ mod adegwat għal trattamenti oħra.
For more information, see the Package Leaflet.
Għal iktar tagħrif, ara l- Fuljett ta ’ Tagħrif.
The medicine can only be obtained with a prescription. lP
Il- mediċina tista ’ tinkiseb biss b’ riċetta minn tabib. me
How is Trudexa used?
Kif jintuża Trudexa?
Treatment with Trudexa must be initiated and supervised by a doctor who has experience in the na
Id- doża rakkomandata ta ’ Trudexa hi ta ’ 40 mg mogħtija kull ott
treatment of the diseases that Trudexa is used to treat.
ġimagħtejn bħala injezzjoni waħda taħt il- ġilda.
The recommended dose of Trudexa is 40 mg given every 2 weeks as a single subcutaneous injection (under the skin).
Xi pazjenti bl- artrite rewmatika li jkunu qed jieħdu Trudexa mingħajr methotrexate jistgħu jibbenefikaw mit- teħid ta ’ din id- doża kull ġimgħa.
Some patients with rheumatoid arthritis who are taking Trudexa without methotrexate may benefit from taking this dose i dic
Wara li jkunu ngħataw taħriġ, il- pazjenti jistgħu jinjettaw lilhom infushom jekk it- tabib jaqbel.
every week.
Il- pazjenti li od
Patients who take Trudexa must be given the special alert card that summarises the safety information about the medicine.
jkunu qed jieħdu Trudexa għandhom jingħataw karta ta ’ twissija speċjali li tagħti tagħrif fil- qosor dwar is- sigurtà tal- mediċina.
How does Trudexa work?
Kif jaħdem Trudexa?
The active substance in Trudexa, adalimumab, is a monoclonal antibody.
Is- sustanza attiva f’ Trudexa, adalimumab, hi antikorp monoklonali.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Adalimumab ġie ddisinjat biex jeħel ma ’ messaġġier kimiku fil- ġisem 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged and is found at high levels in patients with the diseases that Trudexa is used to treat.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged magħruf bħala fattur tan- nekrożi minn tumur (TNF).
By blocking TNF, adalimumab improves the inflammation and other symptoms of the diseases.
Bl- imblukkar ta ’ TNF, adalimumab itejjeb l- infjammazzjoni u s- sintomi l- oħra tal- mardiet.
How has Trudexa been studied?
Kif ġie studjat Trudexa?
Trudexa has been studied in five studies including almost 2,900 patients with moderate to severe rheumatoid arthritis.
at Trudexa ġie studjat f’ ħames studji li fihom ħadu sehem 2, 900 pazjent bl- artrite rewmatika moderata jew severa.
In four of these studies (involving over 2,000 patients), the effectiveness of
F’ erbgħa minn dawn l- istudji (bis- sehem ta ’ 2, 000 pazjent), l- effikaċja ta ’ Trudexa, waħdu
ed Trudexa, alone or as an as add-on to other anti-inflammatory medicines, including methotrexate, was compared with that of a placebo (a dummy treatment) in patients who generally had taken anti-arthritis medicines in the past.
zz jew flimkien ma ’ mediċini anti- inflammatorji oħra, inkluż methotrexate, tqabblet ma ’ dik ta ’ plaċebo (trattament finta) f’ pazjenti li ġeneralment kienu ħadu mediċini ta ’ kontra l- artrite fl- imgħoddi.
The fifth study included 799 patients, none of whom had taken methotrexate in
Il - ħames studju kien fih 799 pazjent, li l- ebda wieħed minnhom ma kien ħa methotrexate fl- imgħoddi, u
ris the past, and compared the combination of Trudexa and methotrexate to methotrexate or Trudexa alone.
ori qabbel il- kombinazzjoni ta ’ Trudexa u methotrexate ma ’ Trudexa jew methotrexate waħdu.
In all five studies, the main measure of effectiveness was the change in symptoms after 6 months to a year of treatment.
Fil- ħames studji kollha, il- kejl ewlieni ta ’ l- effikaċja kien it- tibdil fis- sintomi wara trattament ta ’ bejn 6 xhur u sena.
tho For psoriatic arthritis, Trudexa was compared to placebo in two studies including 413 patients.
Għall- artrite psorjatika, Trudexa tqabbel ma ’ plaċebo f’ żewġ studji li fihom ħadu sehem 413- il
The medicines were taken alone or in combination with another anti-inflammatory medicine such as methotrexate.
Il- mediċini ttieħdu weħidhom jew flimkien ma ’ mediċini anti- inflammatorji oħra bħal
For ankylosing spondylitis, Trudexa and placebo as an add-on to existing treatment were compared in two studies involving 397 patients.
Għall- ispondilite ankilotika, saru żewġ studji bis- sehem ta ’ 397 pazjent li qabblu l - effettività taż- żieda ta ’ Trudexa u ta ’ plaċebo mat- trattament eżistenti.
For both diseases, the patients had had an
Għaż- żewġ mardiet, il- pazjenti kellhom rispons mhux adegwat għat- terapija preċedenti, u l- kejl ewlieni ta ’ l- effiakċja kien it- tibdil fis- sintomi wara 12- il- ġimgħa ta ’ trattament.
au inadequate response to previous therapy, and the main measure of effectiveness was the change in symptoms after 12 weeks of treatment.
ux X’ inhuma l- benefiċċji ta ’ Trudexa li ntwerew f’ dawn l- istudji?
r What benefit has Trudexa shown during the studies?
L- ikbar tnaqqis
The greatest reductions were seen in the studies examining Trudexa as an add-on to methotrexate: in the two studies taken together, around two thirds of the patients adding 40 mg Trudexa every 2 weeks had at lon least a 20% reduction in symptoms after 6 months, compared to a quarter of those adding placebo.
ad deher fl- istudji li eżaminaw Trudexa meta miżjud ma ’ methotrexate: fiż- żewġ studji meħudin flimkien, madwar żewġ terzi tal- pazjenti li żdidulhom 40 mg ta ’ Trudexa kull ġimagħtejn kellhom tnaqqis fis- sintomi ta ’ mill- inqas 20% wara 6 xhur, meta mqabbla ma ’ kwart minn dawk li żdidilhom ’ g ħ il- plaċebo.
Patients adding Trudexa also had less joint damage and experienced less reduction in physical function than those adding placebo after a year of treatment.
Barra minn hekk, il- pazjenti li żdidilhom Trudexa kellhom inqas ħsara fil- ġogi u għaddew minn inqas tnaqqis fil- funzjoni fiżika minn dawk li żdidilhom il- plaċebo wara sena mit- trattament.
In the patients who had not taken methotrexate before, more patients taking Trudexa and methotrexate had a 50% reduction in symptoms than those taking methotrexate alone over a year of treatment (62% and 46%, respectively). no
Fil - pazjenti li ma kinux ħadu methotrexate qabel, iktar pazjenti li kienu qed jieħdu Trudexa u methotrexate flimkien kellhom tnaqqis ta ’ 50% fis- sintomi milli dawk li kienu qed jieħdu im
For the other two diseases, Trudexa produced a greater improvement in symptoms than placebo.
Għaż- żewġ mardiet l- oħra, Trudexa wassal għal titjib fis- sintomi ikbar mill- plaċebo. li l
What is the risk associated with Trudexa?
X’ inhuma r- riskji asssoċjati ma ’ Trudexa?
In studies of Trudexa, the most common side effects (seen in more than 1 patient in 10) were upper t uc
Fl- istudji dwar Trudexa, l- iktar effetti sekondarji komuni (li dehru f’ iktar minn pazjent wieħed minn kull 10) kienu l- infezzjonijiet respiratorji (irjiħat) u reazzjonijiet fis- sit ta ’ l- injezzjoni (inkluż uġigħ, ina
respiratory infection (colds) and injection site reactions (including pain, swelling, redness or pruritus [itching]).
nefħa, ħmura jew ħakk).
For the full list of rod
Minħabba t- tnaqqis fir- riskju ta ’ infezzjoni, il- pazjenti jridu jiġu sorveljati strettament għal infezzjonijiet fosthom it- tuberkulożi, matul u sa 5 xhur wara t- trattament b’ Trudexa.
all side effects reported with Trudexa, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha li ġew irrappurtati bi Trudexa, ara l- Fuljett ta ’ Tagħrif.
Trudexa should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients.
Trudexa m’ għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal adalimumab jew diċ
Trudexa should not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure. lP
Trudexa m’ għandux jingħata lil pazjenti li jkollhom it - tuberkulożi, infezzjonijiet severi oħra jew ħsara tal- qalb moderat jew sever. me
Why has Trudexa been approved?
Għaliex ġie approvat Trudexa?
The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa’ s benefits are na
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Trudexa jisbqu r- riskji fit- trattament ta ’ l- artrite psorjatika, spondilite ankilotika u artrite rewmatika moderata jew severa fl- adulti fil- każ meta t- trattamenti l- oħra jkunu adegwati.
In rheumatoid arthritis, Trudexa has been shown to reduce the rate at which joint damage gets worse and to improve physical function, when given in combination with methotrexate.
Fl- artrite rewmatika, intwera li Trudexa jnaqqas ir- rata li biha l- ħsara fil- ġogi teħżien u jtejjeb il- funzjoni fiżika, meta ott
be given marketing authorisation.
Il- kumitat irrakkomanda li Trudexa jingħata l- awtorizzazzjoni għat- tqegħid fis- suq. od
Other information about Trudexa:
Informazzjoni oħra dwar Trudexa:
The European Commission granted a marketing authorisation valid throughout the European Union Me
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea Pr
for Trudexa to Abbott Laboratories Ltd. on 1 September 2003.
kollha għal Trudexa lil Abbott Laboratories Ltd. nhar l- 1 ta ’ Settembru 2003.
The full EPAR for Trudexa can be found here.
L- EPAR sħiħ dwar Trudexa jista ’ jinstab hawnhekk.
This summary was last updated in 03-2007.
Dan is- sommarju kien aġġornat l- aħħar fi 03- 2007.
SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lP nai dic Me
at zz ori t aw ux ad ANNESS I ’ g ħ SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT im li l ina diċ me ott od Pr
Trudexa 40 mg solution for injection.
Trudexa 40 mg soluzzjoni għall- injezzjoni
ed Each 0.8 ml single dose vial contains 40 mg of adalimumab.
zz Kull kunjett b’ doża waħda ta ’ 0. 8 ml fih 40 mg adalimumab.
ris For a full list of excipients, see section 6.1.
ori Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
tho 3.
t aw 3.
au 4.
ux 4.
r 4.1 Therapeutic indications
ad 4. 1 Indikazzjonijiet terapewtiċi
ge Rheumatoid arthritis lon Trudexa in combination with methotrexate, is indicated for:
Artrite rewmatika ’ g ħ Trudexa, flimkien ma ’ methotrexate, huwa indikat għall -:
the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been no
• kura ta ’ artrite rewmatika attiva minn moderata sa severa f’ pazjenti adulti, meta r- rispons im
inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. t
tagħhom għal mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard, inkluż methotrexate, ma kienx adegwat. li l
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued uc
• kura ta ’ artrite rewmatika attiva u progressiva severa f’ adulti li ma jkunux ingħataw kura b’ methotrexate qabel. ina
treatment with methotrexate is inappropriate.
Trudexa jista ’ jingħata waħdu f’ każ ta ’ intolleranza għal methotrexate, jew f’ każ li t- tkomplija tal- kura b’ methotrexate ma tkunx tajba.
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and rod
Ġie ppruvat li, meta jingħata flimkien ma ’ methotrexate, Trudexa jnaqqas ir- rata li biha tipprogressa l - diċ
to improve physical function, when given in combination with methotrexate.
ħsara fil- ġogi kif imkejjel permezz ta ’ X- ray, u li jtejjeb il- funzjoni fiżika.
Psoriatic arthritis lP
Artrite Psorjatika me
Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. na
Trudexa huwa ndikat għall- kura ta ’ artrite psorjatika attiva u progressiva f’ adulti meta r- rispons tagħhom għal mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard, inkluż methotrexate, ma jkunx adegwat. ott
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have i
Trudexa huwa indikat għall- kura ta ’ adulti li jbatu minn infjammazzjoni tal- vertebri li jirriżulta fil - od
had an inadequate response to conventional therapy. dic
Pr
Crohn’ s disease Me
Il- marda Crohn (Crohn’ s disease)
Trudexa is indicated for treatment of severe, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/ or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Trudexa huwa indikat għall- marda Crohn severa u attiva f’ pazjenti li, minkejja terapija sħiħa u adekwata li jkunu ingħataw b’ xi corticosteroid u/ jew b’ xi immunosoppressiv, xorta ma kellhomx rispons; jew f’ pazjenti li m’ għandhomx tolleranza għal, jew li jkollhom kontra- indikazzjonijiet mediċi
For induction treatment, Trudexa should be given in combination with cortiocosteroids.
Għall- kura tal- bidu, Trudexa għandu jingħata flimkien ma ’ corticosteroids.
Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
F’ każ ta ’ intolleranza għall- corticosteroids jew f’ każ fejn it- tkomplija tal- kura bil- corticosteroids m’ hijiex adattata, Trudexa jista ’ jingħata waħdu (ara sezzjoni 4. 2).
Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn’ s disease.
zz fid- dijanjosi u fil- kura ta ’ l- artrite rewmatika, ta ’ l- artrite psorjatika, ta ’ l- infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis) jew tal- marda Crohn (Crohn’ s disease).
Patients treated with Trudexa should be given the special alert card.
Pazjenti kkurati b’ Trudexa għandhom jingħataw il- kartuna ta ’ twissija speċjali.
ed After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary.
ori Wara li jingħataw taħriġ xieraq fuq it- teknika ta ’ l- injezzjoni, il- pazjenti jistgħu jinjettaw lilhom infushom b’ Trudexa jekk it- tabib tagħhom jiddeċiedi li dan hu tajjeb għalihom, u jekk ikun hemm
ris During treatment with Trudexa, other concomitant therapies (e. g., corticosteroids and/ or immunomodulatory agents) should be optimised.
aw Matul il- kura b’ Trudexa, terapiji oħra (eż., corticosteroids u/ jew aġenti immunomodulatorji) għandhom jiġu aġġustati għall- aħjar effett.
tho Adults
ux Adulti
au The recommended dose of Trudexa for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
ad Id- doża ta ’ Trudexa rrakkomandata għal pazjenti adulti li jbatu minn artrite rewmatika hija ta ’ 40 mg adalimumab li tittieħed bħala doża waħda ġimgħa iva u ġimgħa le, permezz ta ’ injezzjoni taħt il- ġilda. ’ g ħ Methotrexate għandu jitkompla waqt il- kura b’ Trudexa.
Methotrexate should be continued during treatment with Trudexa.
Mediċini glukokortikojdi, saliċilati u mediċini anti- infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il- kura b’ Trudexa.
r Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued
mediċini anti- rewmatiċi li jaffetwaw il- proċess tal- mard, minbarra methotrexate, ara sezzjoni 4. 4 u 5. 1.
ge during treatment with Trudexa.
Meta Trudexa jingħata bħala kura waħdu, xi pazjenti li jesperjenzaw tnaqqis fir- rispons tagħhom li l
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1. lon In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
jistgħu jibbenefikaw minn żieda fl- intesità tad- doża għal 40 mg kull ġimgħa. ina
Psoriatic arthritis and ankylosing spondylitis no
Artrite Psorjatika u infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis)
The recommended dose of Trudexa for patients with psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. t
Id- doża ta ’ Trudexa rrakkomandata għal pazjenti li jbatu minn artrite psorjatika u infjammazzjoni tal - diċ
For all of the above indications, available data suggest that the clinical response is usually achieved uc
vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis), hija ta ’ 40 mg adalimumab li tittieħed bħala doża waħda ġimgħa iva u ġimgħa le, permezz ta ’ injezzjoni taħt il- ġilda. me
within 12 weeks of treatment.
Għall- indikazzjonijiet kollha t’ hawn fuq, l- informazzjoni li għandna tindika, li s- soltu, ir- rispons kliniku jintlaħaq fi żmien 12 - il ġimgħa ta ’ kura.
Continued therapy should be carefully reconsidered in a patient not responding within this time period. rod
Wieħed għandu jirrikonsidra b’ attenzjoni jekk għandhiex titkompla l- kura f’ każ ta’ pazjent li ma jkunx irrisponda f’ dan il- perijodu ta ’ żmien.
Crohn’ s disease
Il- marda Crohn (Crohn’ s disease) ott
The recommended Trudexa induction dose regimen for adult patients with severe Crohn’ s disease is lP
F’ każ li jkun hemm od
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. na
bżonn ta ’ rispons għat- terapjia aktar mgħaġġel, dożaġġ ta’ 160 mg f’ ġimgħa 0 (id- doża tista ’ tingħata permezz ta ’ erba ’ injezzjonijiet f’ ġurnata waħda jew inkella bħala żewġ injezzjonijiet kull ġurnata għal jumejn konsekuttivi) u 80 mg f’ ġimgħa 2 jista ’ jingħata però, f’ dan il- każ, wieħed għandu jżomm Pr
Alternatively, if a patient has stopped Trudexa and signs and symptoms of disease recur, i dic
Jew inkella, jekk pazjent ikun waqaf jieħu Trudexa u s- sinjali u s- sintomi tal -
Trudexa may be re-administered.
3 marda jerġgħu joħorġu, Trudexa jista ’ jerġa ’ jingħata.
There is little experience from re-administration after more than 8 weeks since the previous dose.
L- esperjenza dwar it- teħid ta ’ Trudexa għal darba oħra wara li jkunu għaddew aktar minn 8 ġimgħat mill- aħħar doża, hija żgħira.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice Me
Waqt il- kura ta ’ manteniment, il- corticosteroids jistgħu jiġu mnaqqsa ftit ftit sakemm ma jibqgħux jingħataw, u dan skond il- linji gwida tal- prattika klinika.
guidelines.
zz tad- doża għal 40 mg Trudexa kull ġimgħa.
Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week.
Xi pazjenti li ma jkollhomx rispons sa ġimgħa 4 jistgħu jibbenefikaw minn terapija ta ’ manteniment li
3 Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
ori titkompla sa ġimgħa 12.
Elderly patients
t Pazjenti anzjani
ed No dose adjustment is required.
aw M’ hemmx bżonn ta ’ aġġustament tad- doża.
ris There is no experience in children.
ux M’ hemmx esperjenza dwar l- użu fit- tfal.
tho Impaired renal and/ or hepatic function
ad Indeboliment tal- funzjoni renali u/ jew tal- fwied
Trudexa has not been studied in these patient populations.
Trudexa ma ġiex studjat fuq dawn il- populazzjonijiet ta ’ pazjenti.
No dose recommendations can be made.
Ma jistgħu jsiru l- ebda ’ g ħ rakkomandazzjonijiet rigward doża.
au 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet im
r Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Tuberkulosi attiva jew infezzjonijiet oħra severi bħal sepsis, u infezzjonijiet opportunistiċi (ara li l
ge 4.4).
sezzjoni 4. 4).
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4). lon 4.4 Special warnings and precautions for use
Insuffiċjenza tal- qalb minn moderata sa severa (NYHA klassi III/ IV) (ara sezzjoni 4. 4). ina
Infections no
Infezzjonijiet diċ
Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with Trudexa.
Il- pazjenti għandhom jiġu monitorjati mill- qrib għal infezzjonijiet, inkluż t- tuberkulosi, kemm qabel, waqt, kif ukoll wara l- kura b’ Trudexa.
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period. t uc
Minħabba li l- eliminazzjoni ta ’ adalimumab tista ’ tieħu sa me
Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled. rod
F’ pazjenti li jkollhom infezzjonijiet attivi, li jinkludu infezzjonijiet kroniċi jew lokalizzati, m’ għandhiex tinbeda kura b’ Trudexa sakemm jiġu kontrollati l- infezzjonijiet. ott
Patients who develop a new infection while undergoing treatment with Trudexa should be monitored closely.
Pazjenti li jiżviluppaw infezzjoniji ġdida waqt li jkunu qegħdin taħt il- kura b’ Trudexa, għandhom jiġu monitorjati mill- qrib.
Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled.
F’ każ li pazjent jiżviluppa infezzjoni serja ġdida, it- teħid ta ’ Trudexa għandu jitwaqqaf sakemm l- infezzjonijiet jiġu kontrollati.
Physicians should exercise caution when considering the use of Trudexa in patients with a history of recurring infection or with underlying conditions which may lP
It- tobba għandhom joqogħdu attenti meta jkunu od
predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pr
Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have na
Infezzjonijiet serji, sepsis, tuberkulosi u infezzjonijiet opportunistiċi oħra, li jinkludu fatalitajiet, ġew rapportati b’ Trudexa.
Serious infections: i dic
4 Infezzjonijiet serji:
In clinical trials an increased risk of serious infections in patients receiving Trudexa has been shown, and reports from the post-marketing setting support this finding.
Fi provi kliniċi, irriżulta riskju akbar ta ’ infezzjonijiet serji f’ pazjenti li jirċievu Trudexa, u rapporti li saru wara li l- prodott tpoġġa fis- suq jikkonfermaw dan.
Me
Ta ’ importanza speċjali huma infezzjonijiet bħal pnewmonja, infjammazjoni fil- kliewi (pyelonephritis), artrite settika u settiċemija.
Tuberculosis:
at Tuberkulosi:
There have been reports of tuberculosis in patients receiving Trudexa.
zz Kien hemm rapporti ta ’ tuberkulosi f’ pazenti li jierċievu Trudexa.
It should be noted that in the majority of those reports, tuberculosis was extra-pulmonary, i. e. disseminated.
Wieħed għandu jinnota li fil - maġġoranza ta ’ dawn ir- rapporti, it- tuberkulosi instabet barra mill- pulmun, jiġifieri l- infezzjoni kienet
4 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Qabel tinbeda l- kura b’ Trudexa, il- pazjenti kollha għandhom jiġu evalwati għall- infezzjoni tat -
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
t tuberkulosi kemm attiva kif ukoll mhux attiva (rieqda).
Prescribers
Din l- evalwazzjoni għandha tinkludi l- istorja
ed are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
aw medika fid- dettall, bl- istorja personali tat- tuberkulosi jew esponimenti għal pazjenti b’ tuberkulosi attiva li seta ’ kien hemm fil- passat, u terapija immunosuppressanti li ngħatat fil- passat u/ jew li tkun qiegħda tingħata.
ris If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
Huwa
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local
ux rrakkomandat li l- fatt li dawn it- testijiet saru għandu jitniżżel fuq il- kartuna ta ’ twissija tal- pazjent.
tho recommendations must be initiated before starting treatment with Trudexa.
ad Jekk ikun hemm dijanjosi ta ’ tuberkulosi attiva, it- terapija b’ Trudexa m’ għandhiex tinbeda (ara sezzjoni 4. 3). ’ g ħ Jekk ikun hemm dijanjosi ta ’ tuberkulosi rieqda, għandhom jinbdew profilassi xierqa għal kontra t - tuberkulosi skond rakkomandazzjonijiet lokali, qabel tinbeda l- kura b’ Trudexa.
In this situation, the benefit/ risk balance of therapy with Trudexa should be very carefully considered.
F’ din is- sitwazzjoni, il- bilanċ tal- benefiċju/ riskju tat- terapija b’ Trudexa għandu jiġi kkunsidrat b’ attenzjoni kbira. im
Patients should be instructed to seek medical advice if signs/ symptoms (e. g., persistent cough,
Il- pazjenti għandhom ikunu avżati biex jitolbu parir mediku jekk sinjali/ sintomi (eż, sogħla persisitenti, telf ta ’ muskoli/ tnaqqis fil- piż, deni ta ’ grad baxx) li jindikaw infezzjoni tat- tuberkulosi li l
au wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Trudexa.
ifeġġu waqt jew wara t- terapija b’ Trudexa.
r Other opportunistic infections:
Infezzjonijiet opportunistiċi oħra: ina
ge There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and lon aspergillosis.
Kien hemm rapporti ta ’ infezzjonijiet opportunistiċi serji u severi assoċjati mat- terapija b’ Trudexa, per eżempju pnewmonja pneumocystis carinii, histoplasmosis mifruxa, listeriosis u aspergillosis. diċ
If a patient receiving Trudexa shows prolonged/ atypical symptoms/ signs of infections or general deterioration, prevalent opportunistic conditions must be considered. no
Jekk pazjent li jircievi Trudexa juri sintomi/ sinjali ta ’ infezzjoni jew deterjorament ġenerali fit - tul/ atipiċi, għandhom jiġu kkunsdrati kundizzjonijiet opportunistiċi prevalenti. me
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Trudexa, who are chronic carriers of this virus.
Seħħet riattivazzjoni ta ’ epatite B f’ pazjenti li jġorru dan il- virus b’ mod kroniku u li jirċievu xi antagonist ta ’ TNF, inkluż Trudexa.
Some cases have had fatal outcome.
Xi każi kellhom riżultat fatali.
Patients at risk for HBV t uc
Qabel ma tinbeda t- terapija b’ Trudexa, pazjenti li qegħdin f’ riskju li jaqbadhom infezzjoni HBV għandhom jiġu eżaminati għal ott
infection should be evaluated for prior evidence of HBV infection before initiating Trudexa therapy.
evidenza ta ’ infezzjoni HBV li seta ’ kellhom qabel.
Carriers of HBV who require treatment with Trudexa should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination rod
M’ hawnx informazzjoni adegwata fuq il- kura od
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
ta ’ pazjenti li jġorru l- HBV permezz ta ’ terapija anti- virali flimkien ma ’ terapija b’ antagonist ta ’ TNF biex tiġi evitata r- riattivazzjoni ta ’ l- HBV.
In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. lP
Trudexa għandu jitwaqqaf u għandha tinbeda terapija anti - virali effettiva akkumpanjata b’ kura adegwata supportiva f’ każ ta ’ pazjenti li jiżviluppaw Pr
Neurological events
riattivazzjoni ta ’ l- HBV.
TNF-antagonists including Trudexa have been associated in rare cases with new onset or exacerbation na
Effetti Newroloġiċi
of clinical symptoms and/ or radiographic evidence of demyelinating disease.
5 Antagonisti- TNF, inluż Trudexa, ġew assoċjati f’ każi rari, ma ’ sintomi kliniċi ġodda jew taħrix ta ’ sintomi kliniċi u/ jew evidenza radjografika ta ’ mard li jaffetwaw il- myelin tan- nervituri.
Prescribers should exercise caution in considering the use of Trudexa in patients with pre-existing or recent-onset central nervous system demyelinating disorders. i dic
Min jagħti l - mediċina għandu joqgħod attent meta jikkunsidra l- użu ta ’ Trudexa fuq pazjenti li diġà għandhom jew li qabduhom riċentement, disturbi li jaffetwaw il- myelin fis- sistema ċentrali nervuża.
Allergic reactions
at Reazzjonijiet allerġiċi
Serious allergic adverse reactions have not been reported with subcutaneous administration of Trudexa Me
zz Matul provi kliniċi, ma ġewx irrappurtati reazzjonijiet avversi serji bl- użu ta ’ Trudexa taħt il- ġilda.
during clinical trials.
Reazzjonijiet allerġiċi li m’ humiex serji assoċjati ma ’ Trudexa, ma kinux komuni matul il- provi kliniċi.
Non-serious allergic reactions associated with Trudexa were uncommon during clinical trials.
Wara li l- prodott tqiegħed fis- suq, reazzjonijiet allerġiċi serji, li jinkludu l- anafilassi, ġew
In postmarketing, serious allergic reactions including anaphylaxis have been reported very rarely following Trudexa administration.
ori irrappurtati f’ każi rari ħafna wara li ttieħed Trudexa.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
Jekk ikun hemm reazzjoni anafilattika jew reazzjoni allerġika serja oħra, it- teħid ta ’ Trudexa għandu jitwaqqaf immedjatament, u għandha tinbeda terapija adattata.
5 The needle cover of the syringe contains natural rubber (latex).
t aw L- għatu tal- labra tas- siringa fih lastiku naturali (latex).
In a study of 64 patients with rheumatoid arthritis that were treated with Trudexa, there was no
ux Fi studju ta ’ 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b’ Trudexa, ma kien hemm l - ebda evidenza ta ’ tnaqqis ta ’ sensitività eċċessiva imdewma, tnaqqis tal- livelli ta ’ immunoglobuli, jew
ed evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B cells and NK-cells, monocyte/ macrophages, and neutrophils.
ad tibdil fin- numri ta ’ ċelloli effettivi T u B u ċelloli NK, monoċistiċi / makrofaġi, u newtrofili.
tho In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Tumuri malinni u disturbi li jaffetwaw it- tkattir tal- limfoċiti ’ g ħ Fil- porzjonijiet kontrollati tal- provi kliniċi ta ’ antagonisti ta ’ TNF, ġew osservati aktar każi ta ’ tumuri malinni, inkluż limfoma, f’ pazjenti li jirċievu xi anagonist ta ’ TNF, meta ipparagunati ma ’ pazjenti kontrollati.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory
Barra minn hekk, hemm sfond ta ’ riskju akbar ta ’ im
au disease, which complicates the risk estimation.
limfoma f’ pazjenti li jbatu minn artrite rewmatika b’ mard infjammatorju li jkun ilu u li hu attiv ħafna, li jikkomplika l- istima tar- riskju.
With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Mill- informazzjoni li għandna s’ issa, ma tistax tiġi eskluża l - possibilità ta ’ żvilupp ta ’ tumuri limfoma jew tumuri malinni oħra f’ pazjenti kkurati b’ xi antagonist ta ’ TNF. li l
r No studies have been conducted that include patients with a history of malignancy or that continue
Ma saru l- ebda studji li jinkludu pazjenti bi storja ta ’ tumuri malinni jew fejn tkompliet il- kura fuq ina
ge treatment in patients who develop malignancy while receiving Trudexa.
pazjenti li jiżviluppaw tumuri malinni waqt li jkunu qegħdin jirċievu Trudexa.
Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8). lon In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
jbatu minn mard kroniku li jimblokka l- pulmun (COPD), minn moderat sa sever, ġew irrappurtati aktar tumuri malinni, l- aktar fil- pulmun, jew ir- ras u l- għonq, f’ pazjenti kkurati b’ infliximab meta pparagunati ma ’ pazjenti kontrollati.
Therefore, caution should be exercised when using any no
Għalhekk, għandha tiġi me
TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
eżerċitata l- attenzjoni meta jintuża kwalukwe antagonist ta ’ TNF f’ pazjenti li jbatu minn COPD, kif ukoll f’ pazjenti li għandhom riskju akbar ta ’ tumur malinn minħabba li jpejpu ħafna.
Haematologic reactions t uc
Reazzjonijiet ematoloġiċi ott
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF blocking agents.
Rapporti rari ta ’ panċitopenja, inkluża anemija aplastika, ġew irrappurtati b’ aġenti li jimblukkaw t - TNF.
Adverse events of the haematologic system, including medically significant cytopoenia (e. g. rod
Il- pazjenti kollha od
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e. g. persistent fever, bruising, bleeding, pallor) while on Trudexa.
għandhom ikunu avżati biex ifittxu l- attenzjoni medika jekk jiżviluppaw sinjali u sintomi li jindikaw tibdil fil- livelli taċ- ċelloli tad- demm (eż deni persistenti, tbenġil, ħruġ ta ’ demm, sfurija) waqt li jkunu qegħdin jirċievu Trudexa.
Discontinuation of Trudexa therapy should be considered in patients with confirmed significant haematologic lP
Għandu jiġi kkunsidrat it- twaqqif tal- kura b’ Trudexa f’ pazjenti li ġew Pr
abnormalities.
kkonfermati li għandhom abnormalitajiet ematoloġiċi sinifikanti.
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent na
Tilqim
virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
6 Fi studju li sar fuq 226 suġġetti adulti li jbatu minn artrite rewmatika u li kienu kkurati b’ adalimumab jew bil- plaċebo, ġew osservati risponsi simili ta’ anti- korpi għat- tilqima b’ vaċċin stàndard 23- valent ta ’ newmokokku u t- tilqima tal- virus trivalenti ta ’ l- influwenza.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Trudexa.
M’ hawn l- ebda informazzjoni dwar it - trasmissjoni sekondarja ta ’ l- infezzjoni permezz ta ’ vaċċini ħajjin f’ pazjenti li jirċievu Trudexa.
Patients on Trudexa may receive concurrent i dic
Pazjenti li jkunu qegħdin fuq il- kura b’ Trudexa jistgħu jirċievu tilqim f’ daqqa, minbarra vaċċini ħajjin.
vaccinations, except for live vaccines.
at Insuffiċjenza tal- qalb konġestiva
Congestive heart failure Me
Każi ta ’ fejn l -
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
ori insuffiċjenza tal- qalb konġestiva marret għall- agħar ġew irrappurtati ukoll f’ pazjenti li jirċievu Trudexa.
Cases of worsening congestive heart failure have also been reported in patients receiving Trudexa.
Trudexa għandu jintuża b’ attenzjoni f’ pazjenti li jbatu minn insuffiċjenza tal- qalb ħafifa (NYHA Klassi I/ II).
Trudexa should be used with caution in patients with mild heart failure (NYHA class I/ II).
Trudexa huwa kontro- indikat f’ pazjenti li jbatu minn insuffiċjenza tal- qalb minn
Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Il- kura b’ Trudexa għandha titwaqqaf f’ pazjenti li jiżviluppaw
Treatment with Trudexa must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
aw sintomi ġodda jew li jiggravawlhom is- sintomi eżistenti ta ’ insuffiċjenza tal- qalb konġestiva.
6 Autoimmune processes
Proċessi awtoimmuni
Treatment with Trudexa may result in the formation of autoimmune antibodies.
ux Il- kura b’ Trudexa tista ’ tirriżulta fil- formazzjoni ta’ anti- korpi awtoimmuni.
The impact of long- term treatment with Trudexa on the development of autoimmune diseases is unknown.
L- impatt tal- kura b ’ Trudexa fit- tul fuq l- iżvilupp ta ’ mard awtoimmuni m’ huwiex magħruf.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Trudexa and is positive for antibodies against double-stranded DNA, further treatment with Trudexa should not be
Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis- sindromu tal- lupus wara li tkun ingħatat kura b’ Trudexa, u
Concurrent administration of TNF-antagonists and anakinra
ad jkun pożittiv għall- anti- korpi kontra DNA li hi double stranded, m’ għandhiex tingħata aktar kura b’ Trudexa (ara sezzjoni 4. 8). ’ g ħ L- għoti flimkien ta ’ antagonisti ta ’ TNF u anakinra
Because of
Fi studji kliniċi fejn intużaw flimkien anakinra u antagonist ieħor ta ’ TNF, etanercept, ġew osservati infezzjonijiet serji, u ma kienx hemm żieda ta ’ xi benefiċju kliniku meta pparagunat ma ’ l- għoti ta ’ im
tho the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Minħabba n- natura ta ’ l- effetti avversi li ġew osservati bil- kura ta ’ etanercept u anakinra flimkien, tossiċitajiet simili jistgħu jirriżultaw ukoll ma ’ l- għoti ta ’ anakinra flimkien ma ’ antagonisti ta ’ TNF oħra.
Therefore, the combination of adalimumab and anakinra is not recommended.
Għalhekk, l- għoti flimkien ta’ nadalimumab u anakinra m’ huwiex li l
au Surgery
Kirurġija ina
There is limited safety experience of surgical procedures in patients treated with Trudexa.
L- esperjenza ta ’ sigurtà ta ’ proċeduri kirurġiċi f’ pazjenti kkurati b’ Trudexa hija limitata.