qanastek/EMEA-V3 huggingface dataset:
So any vaginal bleeding while you take OPTRUMA is unexpected.
G alhekk, jekk hemm xi demm ej mill- va ina waqt li qed tie u OPTRUMA dan mhux mistenni.
You should have this investigated by your doctor.
G andek tkun investigata mit- tabib tieg ek.
OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.
OPTRUMA ma tne ilekx is- sintomi li jitfa aw wara l- menopawsa, b all- fwawar.
OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol.
OPTRUMA tbaxxilek il- livell totali tal- kolesterol u tal - kolesterol LDL (dak li hu ‘ a in ’).
In general, it does not change triglycerides or HDL ("good") cholesterol.
B ala regola enerali m’ g andhiex effett fuq it- trigli eridi jew il - kolesterol HDL (dak li hu ‘ tajjeb ’).
However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking OPTRUMA.
Madankollu, jekk kont tie u l- estro enu fil- passat u kellek livelli g oljin afna ta ’ trigli eridi, g andek tkellem lit- tabib tieg ek qabel tie u OPTRUMA.
Taking other medicines
Meta tie u medi ini o ra
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek jekk qieg da tie u jew adt dan l- a ar xi medi ini o ra, anki dawk ming ajr ri etta.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Jekk qieg da tie u xi medi ini g all- qalb li fihom id- di italis jew qieg da tie u xi antikoagulanti b al warfarin biex traqaq id- demm, hemm il- possibilità li t- tabib tieg ek ikollu b onn jag mel xi tibdil g ir fid- do a ta ’ dawn il- medi ini.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
G id lit- tabib tieg ek jekk qieg da tie u cholestyramine, medi ina li tintu a l- i jed biex tbaxxi l - livelli tax- xa am fid- demm.
Pregnancy and breast-feeding OPTRUMA is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Tqala u Treddig OPTRUMA hija biss g all- u u minn nisa wara l- menopawsa u m’ g andhiex tittie ed minn nisa li g ad jista ’ jkollhom tarbija.
Optruma could harm your unborn child.
Optruma tista ’ tag mel sara lit- tarbija tieg ek li g ad trid titwieled.
Do not take OPTRUMA if you are breast-feeding as it might be excreted in mother 'milk. s
Tie ux OPTRUMA jekk inti qed tredda ’ g ax tista ’ to ro fil - alib tas- sider.
OPTRUMA has no known effects on driving or using machines.
Sewqan u t addim ta ’ magni OPTRUMA m’ g andhiex effetti mag rufa fuq is- sewqan jew it- t addim ta ’ magni.
Important information about some ingredients of OPTRUMA:
Tag rif importanti dwar xi sustanzi ta ’ OPTRUMA:
If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product..
Jekk ejt mg arraf mit- tabib tieg ek li g andek xi intolleranza g al- lactose, tip ta ’ zokkor, ikkuntattja lit- tabib tieg ek qabel ma tie u dan il- prodott medi inali.
HOW TO TAKE OPTRUMA
KIF TITTIE ED OPTRUMA
Always take this product exactly as your doctor has told you.
Dejjem g andek tie u dan il- prodott skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
G andek ta erta ru ek mat- tabib jew ma ’ l- ispi jar tieg ek jekk ikollok xi dubju.
The dose is one tablet a day.
24 Id- do a hija pillola wa da kuljum.
You may take it with or without food.
Ma tag milx differenza f’ liema in tal - urnata tie u l- pillola tieg ek, i da jekk tie u l- pillola fl- istess in kuljum, dan jg in biex tiftakar te odha. Tista ’ te odha ma ’ l- ikel jew fuq stonku vojt.
The tablets are for oral use.
Il- pilloli huma g all- u u orali.
24 Swallow the tablet whole.
Ibla ’ l- pillola s i a.
If you wish you may take a glass of water with it.
Jekk trid, tista ’ tni ilha b’ tazza ilma.
Your doctor will tell you how long you should continue to take OPTRUMA.
It- tabib tieg ek sejjer jg idlek g al kemm mien g andek tie u OPTRUMA.
The doctor may also advise you to take calcium and vitamin D supplements.
It- tabib g andu mnejn jag tik parir biex tie u supplimenti tal- calcium u tal- vitamina D.
You should talk to your doctor first.
Jekk tieqaf tie u OPTRUMA G andek tkellem l- ewwel lit- tabib tieg ek.
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.
Jekk g andek l- impressjoni li l- effett ta ’ dan il- prodott huwa qawwi wisq jew fjakk wisq, kellem lit - tabib tieg ek jew lill- ispi jar.
Take a tablet as soon as you remember and then continue as before.
Jekk tinsa tie u OPTRUMA u l- pillola hekk kif tiftakar, imbag ad kompli b as- soltu.
Tell your doctor or pharmacist.
Jekk tie u OPTRUMA aktar milli suppost Staqsi lit- tabib tieg ek jew lill- ispi jar.
Like all medicines, OPTRUMA can cause side effects although not everybody gets them.
B al kull medi ini o ra, OPTRUMA jista ’ jkollha effetti sekondarji, g alkemm ma jidhrux fuq kul add.
The majority of side effects seen with OPTRUMA have been mild.
Il- ma oranza ta ’ l- effetti sekondarji li dehru b’ OPTRUMA kienu fief.
The most common side effects (affects more than 1 user in 10) are: • Hot flushes (vasodilatation) • Flu syndrome
L- aktar effetti sekondarji komuni (jaffettwaw aktar minn pazjent 1 minn kull 10) huma: • Fwawar (va odilatazzjoni) • Sindromu ta ’ l- influwenza
Common side effects (affects 1 to 10 users in 100) are: • Leg cramps • Swelling of hands, feet and legs (peripheral oedema) • Gallstones
Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 100) huma: • Bug awwi ijiet fir- ri lejn • Nef a ta ’ l- idejn, tas- saqajn u tar- ri lejn (edima periferali) • ebel fil- marrara
Uncommon side effects (affects 1 to 10 users in 1000) are: • Increased risk of blood clots in the legs (deep vein thrombosis) • Increased risk of blood clots in the lungs (pulmonary embolism) • Increased risk of blood clots in the eyes (retinal vein thrombosis) • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 1000) huma: • Riskju og la ta ’ koaguli tad- demm fir- ri lejn (trombo i tal- vini fil- fond) • Riskju og la ta ’ koaguli tad- demm fil- pulmuni (emboli mu pulmonari) • Riskju og la ta ’ koaguli tad- demm fl- g ajnejn (trombo i fil- vina tar- retina) • Il - ilda madwar vina tkun amra u tu a ’ (tromboflebite tal- vini superfi jali)
Very rare side effects (affects less than 1 user in 10,000) are: • Rash • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset • Increased blood pressure • Decrease in the number of the platelets in the blood • Blood clot in an artery (for example stroke) • Headache including migraine • Mild breast symptoms such as pain, enlargement and tenderness
Raxx Sintomi gastro- intestinali b al tqallig, rimettar, u ig addominali u stonku mqalleb ieda fil- pressjoni tad- demm Tnaqqis fin- numru ta ’ plejtlits fid- demm Formazzjoni ta ’ embolu f’ xi arterja (per e empju puplesija) U ig ta ’ ras inklu a l- emikranja Sintomi fief fis- sider b al u ig, ieda fid- daqs u fis- sensittività
In rare cases, blood levels of liver enzymes may increase during treatment with OPTRUMA.
F’ ka ijiet rari afna, waqt kura b’ OPTRUMA jistg u ji diedu l- livelli ta ’ l- enzimi tal- fwied fid- demm.
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.
25 Jekk xi wie ed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok, g id lit- tabib jew lill- ispi jar tieg ek.
HOW TO STORE OPTRUMA
EN OPTRUMA
Do not use after the expiry date which is stated on the pack.
Tu ahx wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Medicines should not be disposed of via wastewater or household waste.
Il- medi ini m’ g andhomx jintremew ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
Dawn il- mi uri jg inu g all - protezzjoni ta ’ l- ambjent.
What OPTRUMA contains
X’ fiha OPTRUMA
- The other ingredients of OPTRUMA tablets are:
- Is- sustanzi l- o ra tal- pilloli ta ’ OPTRUMA huma:
What OPTRUMA looks like and contents of the pack OPTRUMA are white, oval, film coated tablets which are marked with the number 4165.
Id- Dehra ta ’ OPTRUMA u l- kontenuti tal- pakkett OPTRUMA huma pilloli bojod, ovali, miksija b’ rita u li g andhom in- numru 4165 stampat fuqhom.
They are packed in blisters or in plastic bottles.
Ji u o folji jew fi fliexken tal- plastik.
The blister boxes contain 14, 28, or 84 tablets.
Il- kaxex tal- folji fihom 14, 28 jew 84 pilloli.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g all- skop kummer jali.
Marketing Authorisation Holder Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Id- Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq
Manufacturer
Eli Lilly Nederland B. V, Grootslag 1- 5, NL- 3991 RA Houten, L- Olanda
26 For any information about this medicinal product, please contact the representative of Eli Lilly in your country:
26 G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok ikkuntattja lir- rapprezentant ta ’ Eli Lilly fil- pajji tieg ek:
-
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.!. ".!.
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#$: +30 210 629 4600
* +: +30 210 629 4600%
27 Sverige Phadisco Ltd #$: +357 22 715000
Sverige Phadisco Ltd * +: +357 22 715000%
Latvija Eli Lilly Holdings Limited p%rst%vniec & ba Latvij% Tel: +371 67364000
27 Latvija Eli Lilly Holdings Limited p, rst, vniec- ba Latvij, Tel: +371 67364000
This leaflet was last approved on:
ar approvat f ’:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- medi ina tinsab fuq il- website ta ’ l- A enzija Ewropeja dwar il - Medi ini (EMEA) http: // www. emea. europa. eu.
What is ORENCIA?
X’ inhu ORENCIA?
ORENCIA is a vial containing a powder to be made up into a solution for infusion.
ORENCIA hu fjala li jkun fiha trab li jista ’ jinħall biex jifforma soluzzjoni għall- infużjoni.
Each vial contains 250 mg of the active substance abatacept.
Kull fjala fiha 250 mg tas- sustanza attiva abatacept.
What is ORENCIA used for?
Għal x’ hiex jintuża ORENCIA?
ORENCIA is an anti-inflammatory medicine that is used in combination with methotrexate (another medicine that acts on the immune system) to treat adults with moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
ORENCIA hu mediċina anti- infjammatorja li tintuża flimkien ma ’ methotrexate (mediċina oħra li taġixxi fuq is- sistema immunitarja) biex titratta adulti bl- artrite tar- rewmatiżmu moderata jew severa (marda tas- sistema immunitarja li tikkawża ħsara u infjammazzjoni fil- ġogi).
ORENCIA is used in patients who have not had a sufficient response to other medicines for rheumatoid arthritis including at least one ‘ tumour necrosis factor (TNF) blocker’, or who cannot be given these medicines.
OREANCIA jintuża f’ pazjenti li ma jkunux irrispondew biżżejjed għal mediċini oħra għall- artrite tar- rewmatiżmu fosthom għallinqas inibitur ta ’ fattur ta ’ nekrożi tat- tumur (TNF) wieħed, jew li ma jkunux jistgħu jieħdu dawn il- mediċini.
How is ORENCIA used?
Kif jintuża ORENCIA?
Treatment with ORENCIA should be initiated and supervised by a specialised doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
It- trattament b’ ORENCIA għandu jinbeda u jiġi sorveljat minn tabib speċjalizzat li jkollu esperjenza fid- dijanjożi u t- trattament ta ’ l- artrite tar- rewmatiżmu.
ORENCIA is given as an intravenous infusion (drip into a vein) of 500, 750 or 1,000 mg over 30 minutes.
ORENCIA jingħata b’ infużjoni intravenuża (drip ġol- vini) ta ’ 500, 750 jew 1000 mg f’ perjodu ta ’ 30 minuta.
The dose to use depends on the patient’ s weight.
Id- doża tiddependi mill- piż tal- pazjent.
It is given every two weeks in the first month (3 doses), then every 4 weeks.
Jingħata kull ġimagħtejn fl- ewwel xahar (3 dożi), imbagħad kull 4 ġimgħat.
If there is no response within 6 months, doctors should consider the benefits and risks of continuing treatment, and consider alternative treatments.
Jekk ma jkunx hemm rispons f’ 6 xhur, it- tobba għandhom jikkunsidraw il - benefiċċji u r- riskji tat- tkomplija tat- trattament, u għandhom jikkunsidraw trattamenti alternattivi.
How does ORENCIA work?
Kif jaħdem ORENCIA?
The active substance in ORENCIA, abatacept, is a protein that has been designed to suppress the activity of ‘ T-cells’, specific cells in the immune system (the body’ s defence system) that are involved in causing inflammation and joint damage in rheumatoid arthritis.
Is- sustanza attiva f’ ORENCIA, abatacept, hi proteina li ġiet imfassla biex trażżan l- attività tat - ‘ T - cells ’, ċelloli speċifiċi fis- sistema immunitarja (is- sistema ta ’ difiża tal- ġisem) li għandhom x’ jaqsmu mal- ħolqien ta ’ infjammazzjoni u ħsara fil- ġog fl- artrite tar- rewmatiżmu.
T-cells must be ‘ activated ’ before they work.
It- T- cells iridu jiġu ‘ attivati ’ qabel ma jaħdmu.
This happens when some molecules (‘ signals’) bind to receptors on the surface of the T-cell.
Dan isir meta xi molekuli (‘ sinjali ’) jeħlu ma riċetturi fuq il- wiċċ tat- T- cell.
Abatacept has been designed to bind to two of these molecules (CD80 and CD86), preventing them from activating the T-cells.
Abatacept ġie disinjat biex jeħel ma ’ tnejn minn dawn il- molekuli (CD80 u CD86), u b’ hekk jipprevenihom milli jattivaw it- T- cells.
This helps to reduce inflammation, improving the joint damage and other symptoms of the disease.
Dan jgħin fit- tnaqqis ta ’ l- infjammazzjoni, u b’ hekk fit- titjib tal- ħsara fil- ġog u f’ sintomi oħra tal- marda.
Abatacept is produced by a method known as ‘ recombinant DNA technology’.
Abatacept jiġi prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’.
It is made by a cell that has received a gene (DNA), which makes it able to produce abatacept.
Isir minn ċellola li tkun irċeviet ġene (DNA), u dan jagħmilha kapaċi tipproduċi l- abatacept.
(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 How has ORENCIA been studied?
(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 Kif ġie studjat ORENCIA?
The effects of ORENCIA were first tested in experimental models before being studied in humans.
L- effetti ta ’ ORENCIA għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fin - nies.
ORENCIA has been studied in three main studies involving 1,382 patients with rheumatoid arthritis.
ORENCIA ġie studjat fi tliet studji ewlenin li fihom ħadu sehem 1, 382 pazjent bl- artrite sistema.
The first two studies included 991 patients who had not had an adequate response to methotrexate, and the third included 391 patients who had not had an adequate response to TNF blockers in the past.
Fl - ewwel żewġ studji ħadu sehem 991 pazjent li ma kinux irrispondew biżżejjed għal methotrexate, u fit - tielet studju ħadu sehem 391 pazjent li ma kinux irrispondew biżżejjed għat- TNF blockers fil- passat.
All three studies compared the effects of adding ORENCIA or placebo (a dummy treatment) to the other medicines that the patients were already taking for rheumatoid arthritis: these did not include a TNF blocker.
It- tliet studji qabblu l- effetti taż- żieda ta ’ ORENCIA jew ta ’ plaċebo (trattament finta) mal- mediċini l - oħra li l- pazjenti kienu qed jieħdu diġà għall- artrite fihom: dawn ma kinux jinkludu TNF blocker.
The main measures of effectiveness were the reduction in symptoms of arthritis after 6 months of treatment, as well as physical function and the amount of damage to the joints (assessed using X rays).
Il - mezzi ewlenin tal- kejl ta ’ l- effettività kienu t- tnaqqis fis- sintomi ta ’ l- artrite wara 6 xhur trattament, kif ukoll il- funzjoni fiżika u l- ammont ta ’ ħsara (valutata bl- użu tar- raġġi X).
An additional study compared the effects of adding ORENCIA, infliximab (a TNF blocker) or placebo to treatment containing methotrexate.
Studju addizzjonali qabbel l- effetti taż- żieda ta ’ ORENCIA, infliximab (TNF blocker) jew plaċebo mat- trattament b’ methotrexate.
This study included 266 patients who had not responded adequately to methotrexate.
F’ dan l- istudju ħadu sehem 266 pazjent li ma kinux irrispondew biżżejjed għal methotrexate.
What benefit has ORENCIA shown during the studies?
X’ inhuma l- benefiċċji ta ’ ORENCIA li ħarġu minn dawn l- istudji?
ORENCIA was more effective than placebo in improving the symptoms of rheumatoid arthritis in all studies.
ORENCIA kien iktar effettiv mill- plaċebo fit- titjib tas- sintomi ta ’ l- artrite biżżejjed fl- istudji kollha.
In the first study, 70 (60.9%) of the 115 patients adding the approved dose of ORENCIA to methotrexate had at least a 20% reduction in symptoms, compared to 42 (35.3%) of the 119 adding placebo.
Fl- ewwel studju, 70 (60. 9%) mill- 115- il pazjent li żiedu d- doża approvata ta ’ ORENCIA ma ’ methotrexate kellhom ta ’ l- inqas tnaqqis ta ’ 20% fis- sintomi meta imqabbla ma ’ 42 (35. 5%) mill- 119 li kienu ħadu l- plaċebo.
The second study showed a similar effect of ORENCIA on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
It- tieni studju wera effett simili ta ’ ORENCIA fuq is- sintomi ta ’ l- artrite rewmatika, kif ukoll titjib fil- funzjoni fiżika u tnaqqis fir- rata ta ’ ħsara fil- ġog wara sena trattament.
In the study of patients with an inadequate response to TNF blockers in the past, adding ORENCIA to existing treatment led to 129 (50.4%) of the 256 patients having at least a 20% reduction in symptoms, compared with 26 (19.5%) of the 133 patients adding placebo.
Fl- istudju b’ pazjenti li ma rrispondewx biżżejjed għat- TNF blockers fil- passat, iż- żieda ta ’ ORENCIA għat- trattament eżistenti wasslet biex 129 (50. 4%) mill- 256 pazjent kellhom tnaqqis ta ’ mill- inqas 20% fis- sintomi, meta imqabbla ma ’ 26 (19. 5%) mill- 133 pazjent li kienu żiedu l- plaċebo.
Patients taking ORENCIA also had a greater improvement in physical function after 6 months.
Il- pazjenti li ħadu ORENCIA kellhom ukoll titjib ikbar fil- funzjoni fiżika wara 6 xhur.
The additional study confirmed the improvement in symptoms with ORENCIA in patients who had not responded adequately to methotrexate.
L- istudju addizjonali ikkonferma t- titjib fis- sintomi permezz ta ’ ORENCIA f’ pazjenti li ma kinux irrispondew biżżejjed għal methotrexate.
The response after 6 months was similar to that seen with infliximab.
Ir- rispons wara 6 xhur kien jixbah lil dak li deher bl- użu ta ’ infliximab.
What is the risk associated with ORENCIA?
X’ inhuma l- effetti sekondarji marbuta ma ’ ORENCIA?
The most common side effect when taking ORENCIA (seen in more than 1 patient in 10) is headache.
L- iktar effett sekondarji komuni tat- teħid ta ’ ORENCIA (li dehru f’ iktar minn pazjent wieħed minn kull 10) hu l- uġigħ ta ’ ras.
For the full list of all side effects reported with ORENCIA, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rappurtati b’ ORENCIA, ara l- Fuljett ta ’ Tagħrif.
ORENCIA should not be used in patients who may be hypersensitive (allergic) to abatacept or any of the other ingredients.
ORENCIA m’ għandux jingħata lil pazjenti allerġiċi għall- abatacept jew għal xi sustanza oħra tiegħu.
It should also not be used in patients with severe and uncontrolled infections, such as sepsis (serious blood infection) or ‘ opportunistic’ infections (infections seen in patients with damaged immune systems).
Lanqas m’ għandu jingħata lil pazjenti li jkollhom infezzjonijiet severi jew mhux ikkontrollati, bħal sepsis (infezzjoni serja fid- demm) jew infezzjonijiet ‘ opportunistiċi ’ (infezzjonijiet li jaffettwaw pazjenti bi ħsara fis- sistema immunitarja).
Patients who take ORENCIA are given a special alert card that explains this restriction, and instructs them to contact their doctor immediately if they develop an infection during a course of treatment with ORENCIA.
Pazjenti li jieħdu ORENCIA jingħataw kard ta ’ twissija speċjali li tispjega din ir- restrizzjoni, u tagħtihom istruzzjonijiet biex jikkuntattjaw lit- tabib tagħhom immedjatament jekk ikollhom xi infezzjoni waqt li jkunu qed jieħdu ORENCIA.
Why has ORENCIA been approved?
Għaliex ġie approvat ORENCIA?
The Committee for Medicinal Products for Human Use (CHMP) concluded that ORENCIA had a modest anti-inflammatory effect, and in combination with methotrexate, led to a reduction in the worsening of joint damage and an improvement in physical function.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li ORENCIA għandu effett anti- inflammatorju moderat, u li, meta meħud flimkien ma ’ methotrexate, wassal għal tnaqqis fl- iggravar tal- ħsara fil- ġog u għal titjib fil- funzjoni fiżika.
The committee decided that ORENCIA’ s benefits are greater than its risks for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one TNF inhibitor.
Il- kumitat iddeċieda li l- benefiċċji ta ’ ORENCIA huma ikbar mir- riskji meta jintuża fit- trattament ta ’ l- artrite tar- rewmatiżmu attiva moderata jew severa fil- pazjenti adulti li ma kinux irrispondew biżżejjed jew li kellhom intolleranza għal mediċini oħra antirewmatiċi li jimmodifikaw il- marda fosthom mill- inqas TNF inhibitor wieħed.
It recommended that ORENCIA be given marketing authorisation.
Il- kumitat irrakkomanda li ORENCIA jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about ORENCIA:
Tagħrif ieħor dwar ORENCIA:
The European Commission granted a marketing authorisation valid throughout the European Union for ORENCIA to Bristol-Myers Squibb Pharma EEIG on 21 May 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE kollha għal ORENCIA lil Bristol- Myers Squibb Pharma EEIG fit- 21 ta ’ Mejju 2007.
The full EPAR for ORENCIA can be found here.
L- EPAR sħiħ dwar ORENCIA jista ’ jinstab hawnhekk.
This summary was last updated in 04-2007.
Dan is- sommarju kien aġġornat l- aħħar fi 04- 2007.
Pharmaceutical Form Powder for concentrate for solution for infusion
Trab u konċentrat għal soluzzjoni
Package size 1 vial + 1 syringe
1 kunjett +
Powder for concentrate for solution for infusion
Trab u konċentrat għal soluzzjoni għall- infużjoni
2 vials + 2 syringes
2 kunjetti + 2 siringi
3 vials + 3 syringes
3 kunjetti + 3 siringi
ORENCIA 250 mg powder for concentrate for solution for infusion.
ORENCIA 250 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni.
Each vial contains 250 mg of abatacept.
Kull kunjett fih 250 mg ta 'abatacept.
Each ml contains 25 mg of abatacept, after reconstitution.
Wara rikonstituzzjoni, kull ml fih 25 mg ta 'abatacept.
Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells.
Abatacept huwa proteina tal- fużjoni magħmula permezz ta ’ teknoloġija tad- DNA rikombinanti f’ ċelluli ta ’ l- ovarju tal- ħamster Ċiniż.
Excipient: sodium:
Sustanza mhux attiva: sodium:
0.375 mmol per vial
0. 375 mmol f’ kull kunjett
The powder is a white to off-white whole or fragmented cake.
It- trab huwa bajdani għal offwajt sħiħ jew kejk imfarrak.
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one tumour necrosis factor (TNF) inhibitor.
ORENCIA meta kkombinat ma ’ methotrexate huwa indikat għat- trattament ta ’ l- artrite tar - rewmatiżmu attiva li tkun minn moderata għal serja, f’ pazjenti adulti li kellhom respons insuffiċjenti jew intolleranza għal mediċini oħra ta ’ kontra r- rewmatiżmu li jimmodifikaw l- marda inkluż għallinqas inibitur ta ’ fattur ta ’ nekrożi tat- tumur (TNF) wieħed.
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
Waqt trattament ikkombinat ta ’ abatacept ma ’ methotrexate, intwera kemm tnaqqis fil- progressjoni tal- ħsara fil- ġogi kif ukoll titjib fil - funżjoni fiżika.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
It- trattament irid jinbeda u jiġi sorveljat minn tobba speċjalisti b’ esperjenza fid- dijanjożi u t- trattament ta ’ artrite tar- rewmatiżmu.
Adults To be administered as a 30-minute intravenous infusion at the dose specified in Table 1.
Adulti Għandu jingħata bħala infużjoni fil- vini fuq 30 minuta b’ doża speċifikata f’ Tabella 1.
Following the initial administration, ORENCIA should be given 2 and 4 weeks after the first infusion, then every 4 weeks thereafter. a
Wara l- ewwel għotja tiegħu, ORENCIA għandu jingħata 2 u 4 ġimgħat wara l- ewwel infużjoni, u mbagħad, kull erba ’ ġimgħat. a
Dose of ORENCIA
ORENCIA
Body Weight of Patient
Numru ta ’ b Kunjetti
Dose
Pazjent
Number of Vialsb
Doża
< 60 kg
< 60 kg ≥ 60 kg sa ≤ 100 kg
1,000 mg
1, 000 mg
Approximating 10 mg/ kg. b Each vial provides 250 mg of abatacept for administration.
Bejn wieħed u ieħor 10 mg/ kg. b Kull kunjett jipprovdi 250 mg ta ’ abatacept għall- għoti.
Each vial of ORENCIA 250 mg must be reconstituted with 10 ml of water for injections, using the silicone-free syringe provided.
Kull kunjett ta ’ ORENCIA 250 mg irid jiġi rikonstitwit b’ 10 ml ta ’ ilma għall- injezzjonijiet, permezz ta ’ siringa bla silikon ipprovduta mal- prodott.
The reconstituted solution must then be diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection, before administration by intravenous infusion (see section 6.6).
2 100 ml b’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%), qabel ma ’ tingħata bħala infużjoni fil- vini (ara sezzjoni 6. 6).
2 No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
L- ebda aġġustament fid- doża m’ huwa meħtieġ meta jintuża f’ kombinazzjoni ma ’ DMARDs, kortikosterojdi, saliċilati, mediċini għal kontra l- infjammazzjonijiet li m’ humiex sterojdi (NSAIDs), jew analġeżiċi oħra.
If a response to abatacept is not present within 6 months of treatment, the potential benefits of continuing treatment, known and potential risks, and therapeutic alternatives should be considered (see section 5.1).
Jekk ma jkunx hemm respons għal abatacept fl- ewwel 6 xhur ta ’ trattament, għandhom jiġu kkunsidrati l- benefiċċji potenzjali magħrufa jekk jitkompla t- trattament u r- riskji potenzjali, u alternattivi terapewtiċi oħra (ara sezzjoni 5. 1).
Elderly patients No dose adjustment is required.
Pazjenti anzjani M’ hemm bżonn ta ’ l- ebda aġġustament fid- doża.
Paediatric patients There is no experience in children or adolescents.
Pazjenti pedjatriċi M’ hemmx esperjenza dwar l- użu fit- tfal jew fl- adolexxenti.
As a result, the use of ORENCIA in children or adolescents is not recommended until further data become available.
B’ konsegwenza ta ’ dan, l- użu ta ’ ORENCIA fit- tfal jew fl- adolexxenti m’ huwiex rakkomandat sakemm ma jkunx hemm aktar tagħrif disponibbli.
Renal and hepatic impairment ORENCIA has not been studied in these patient populations.
Mard tal- fwied u tal- kliewi ORENCIA ma ġiet studjat f’ dawn il- gruppi ta ’ pazjenti.
No dose recommendations can be made.
Ma tista ’ ssir l- ebda rakkomandazzjoni tad - doża.
Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4).
Infezzjonijiet serji u mhux ikkontrollati bħal sepsis u infezzjonijiet opportunistiċi (ara sezzjoni 4. 4).
Combination with TNF blocking agents There is limited experience with use of abatacept in combination with TNF blocking agents (see section 5.1).
Kombinazzjoni ma ’ sustanzi li jimblokkaw TNF Hemm esperjenza limitata dwar l- użu ta ’ abatacept f’ kombinazzjoni ma ’ sustanzi li jimblokkaw TNF (ara sezzjoni 5. 1).
In placebo-controlled clinical trials, in comparison with patients treated with TNF blocking agents and placebo, patients who received combination TNF blocking agents with abatacept experienced an increase in overall infections and serious infections (see section 4.5).
Fi provi kliniċi kkontrollati bi plaċebo, meta pazjenti ttrattati b’ sustanzi li jimblokkaw TNF tqabblu mal- pazjenti li kienu qed jieħdu plaċebo, pazjenti li rċevew kombinazzjoni ta ’ sustanzi li jimblokkaw TNF ma ’ abatacept, esperjenzaw żieda fl- infezzjonijiet globali u f’ infezzjonijiet serji (ara sezzjoni 4. 5).
Abatacept is not recommended for use in combination with TNF blocking agents.
L- użu ta ’ abatacept flimkien ma ’ sustanzi li jimblokkaw TNF m’ huwiex rakkomandat.
While transitioning from TNF blocking agent therapy to ORENCIA therapy, patients should be monitored for signs of infection.
Waqt it- transizzjoni minn terapija b’ sustanzi li jimblokkaw TNF għal terapija b’ ORENCIA, il- pazjenti jeħtieġu jiġu mmonitorjati għal sinjali ta ’ infezzjoni.
Allergic reactions Allergic reactions have been reported uncommonly with abatacept administration in clinical trials, where patients were not required to be pretreated to prevent allergic reactions (see section 4.8).
Reazzjonijiet allerġiċi Fi provi kliniċi, reazzjonijiet allerġiċi ġew irrapportati fuq bażi mhux komuni ma ’ l- għoti ta ’ abatacept, fejn pazjenti ma kienux meħtieġa li jkunu ttrattati minn qabel biex jipprevjenu reazzjonijiet allerġiċi (ara sezzjoni 4. 8).
Special caution should be exercised in patients with a history of allergic reactions to abatacept or to any of the excipients.
Għandha tingħata attenzjoni partikolari għal dawk il- pazjenti b’ passat mediku ta ’ reazzjonijiet allerġiċi għal abatacept jew għal xi sustanza mhux attiva tiegħu.
If any serious allergic or anaphylactic reaction occurs, ORENCIA therapy should be discontinued immediately and appropriate therapy initiated.
Jekk isseħħ xi reazzjoni allerġika jew anafilattika serja, terapija b’ ORENCIA trid titwaqqaf minnufih u għandha tinbeda terapija addattata.
Effects on the immune system Medicinal products which affect the immune system, including ORENCIA, may affect host defences against infections and malignancies, and affect vaccination responses.
Effetti fuq is- sistema immuni Prodotti mediċinali li jaffetwaw is- sistema immuni, inkluż ORENCIA, jistgħu jaffetwaw id- difiża tal - persuna kontra infezzjonijiet u tumuri malinni, u jaffetwaw ir- respons għat- tilqim.
Co-administration of ORENCIA with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of ORENCIA on the immune system.
L- għoti ta ’ ORENCIA flimkien ma ’ sustanzi immunosuppressivi jew immunomodulatorji bijoloġiċi jistgħu jsaħħu l- effetti ta ’ ORENCIA fuq is- sistema immuni.
There is insufficient evidence to assess the safety and efficacy of ORENCIA in combination with anakinra or rituximab.
M’ hemmx evidenza biżejjed biex tiġi vvalutata s- sigurtà u l- effikaċja ta ’ ORENCIA meta kkombinata ma ’ anakinra jew rituximab.
Infections Serious infections have been reported with abatacept (see section 4.8).
3 Infezzjonijiet Infezzjonijiet serji ġew irrapportati b’ abatacept (ara sezzjoni 4. 8).
Treatment with ORENCIA should not be initiated in patients with active infections until infections are controlled.
F’ pazjenti b’ infezzjonijiet attivi, trattament b’ ORENCIA m’ għandux jinbeda, qabel ma jiġu kkontrollati l- infezzjonijiet.
Patients who develop a
It- tobba jridu joqgħodu attenti meta jikkunsidraw l- użu ta ’ ORENCIA f’ pazjenti b’ pasat mediku ta ’ infezzjonijiet rikorrenti jew li jkollhom xi kundizzjonijiet li jistgħu joħolqulhom predispożizzjoni għal infezzjonijiet.
3 new infection while undergoing treatment with ORENCIA should be monitored closely.
Pazjenti li jiżviluppaw infezzjoni ġdida waqt li jkunu qegħdin jirċievu trattament b’ ORENCIA għandhom jiġu mmonitorjati mill- qrib.
Administration of ORENCIA should be discontinued if a patient develops a serious infection.
L- għoti ta ’ ORENCIA għandu jitwaqqaf jekk il- pazjent jiżviluppa infezzjoni serja.
No increase of tuberculosis was observed in the pivotal placebo-controlled studies.
L- ebda żieda fit- tuberkulożi ma ġiet irrapportata fl- istudji kliniċi ewlenin ikkontrollati bi plaċebo.
Nevertheless, patients should be screened for latent tuberculosis prior to initiating ORENCIA.
Madankollu, il- pazjenti jridu jiġu eżaminati għal tuberkulożi mhux attiva qabel ma dawn jibdew jieħdu ORENCIA.
The available medical guidelines should also be taken into account.
Il- linji gwida mediċi disponibbli għandhom jiġu kkunsidrati wkoll.
Anti-rheumatic therapies have been associated with hepatitis B reactivation.
Terapiji ta ’ kontra r- rewmatiżmu ġew assoċjati ma ’ ri- attivazzjoni ta ’ l- epatite B.
Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA.
Għalhekk, testijiet għall- epatite virali jridu jsiru skond il- linji gwidi ippubblikati qabel ma tinbeda terapija b’ ORENCIA.
Malignancies In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebo-treated patients were 1.4% and 1.1%, respectively (see section 4.8).
Tumuri malinni Fi provi kliniċi kkontrollati bi plaċebo, il- frekwenza ta ’ tumuri malinni f’ pazjenti ttrattati b’ abatacept u bi plaċebo kienet 1. 4% u 1. 1% rispettivament (ara sezzjoni 4. 8).
Patients with known malignancies were not included in these clinical trials.
Pazjenti li diġà kellhom tumuri malinni ma ġewx inklużi f’ dawn il- provi kliniċi.
In carcinogenicity studies in mice, an increase in lymphomas and mammary tumours were noted.
Fi studji dwar il- karċinoġeniċità fuq il- ġrieden, ġiet innotata żieda fil- limfomi u tumuri mammarji.
The clinical significance of this observation is unknown (see section 5.3).
Is- sinifikat kliniku ta ’ din l- osservazjoni m’ huwiex magħruf (ara sezzjoni 5. 3).
The potential role of ORENCIA in the development of malignancies, including lymphoma, in humans is unknown.
Ir- rwol potenzjali ta ’ ORENCIA fl- iżvilupp ta ’ tumuri malinni inkluż limfomi fl- umani m’ huwiex magħruf.
Vaccinations Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation.
Tilqim Ma jistax jingħata tilqim b’ vaċċin tat- tip ħaj flimkien ma ’ ORENCIA jew fi żmien tliet xhur minn meta jitwaqqaf trattament b’ ORENCIA.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ORENCIA.
M’ hemmx tagħrif disponibbli fuq it- trasmissjoni sekondarja ta ’ l- infezzjoni minn persuni li qed jirċievu vaċċin tat- tip ħaj għal pazjenti li qed jieħdu ORENCIA.
Insufficient data are available on the effects of vaccinations in patients receiving ORENCIA.
M’ hemmx biżżejjed tagħrif fuq l- effetti tal- vaċċini f’ pazjenti li qed jirċievu ORENCIA.
Medicinal products that affect the immune system, including ORENCIA, may blunt the effectiveness of some immunisations.
Prodotti mediċinali li jaffettwaw is- sistema immuni inkluż ORENCIA, jistgħu jnaqqsu l- effettività ta ’ xi tilqim.
Elderly patients A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
Pazjenti anzjani Total ta ’ 323 pazjent ta ’ 65 sena jew ikbar, inklużi 53 pazjent ta ’ 75 sena jew ikbar, irċevew abatacept fi provi kliniċi kkontrollati bi plaċebo.
Similar efficacy was observed in these patients and in younger patients.
Effikaċja simili ġiet osservata f’ dawn il- pazjenti u f’ pazjenti iżgħar.
The frequencies of serious infection and malignancy relative to placebo among abatacept-treated patients over age 65 were higher than among those under age 65.
Il- frekwenzi ta ’ infezzjonijiet serji jew ta ’ tumuri malinni meta mqabbla ma ’ plaċebo fost pazjenti ttrattati b’ abatacept li kellhom aktar minn 65 sena, kienu ogħla minn dawk ta ’ taħt il- 65 sena.
Because there is a higher incidence of infections and malignancies in the elderly in general, caution should be used when treating the elderly (see section 4.8).
Minħabba li hemm inċidenza ogħla ta ’ infezzjonijiet u tumuri malinni fl- anzjani b’ mod ġenerali, trattament għall- anzjani għandu jsir b’ kawtela (ara sezzjoni 4. 8).
Autoimmune processes There is a theoretical concern that treatment with ORENCIA might increase the risk for autoimmune processes, for example deterioration of multiple sclerosis.
Proċessi awto- immuni Jeżisti tħassib teoretiku li trattament b’ ORENCIA jista ’ jżid ir- riskju ta ’ proċessi awto- immuni, per eżempju deterjorazzjoni ta ’ sklerożi multipla.
In the placebo-controlled clinical trials, abatacept treatment did not lead to increased autoantibody formation, such as antinuclear and anti- dsDNA antibodies, relative to placebo treatment (see section 4.8).
Fi provi kliniċi kkontrollati bi plaċebo, trattament b’ abatacept ma wassalx għal żieda fil- formazzjoni ta ’ awtoantikorpi, bħal anitkorpi antinukleari u anti - dsDNA, meta mqabbel ma ’ trattament bi plaċebo (ara sezzjoni 4. 8).
Blood glucose testing Parenteral medicinal products containing maltose can interfere with the readings of blood glucose monitors that use test strips with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).
Testijiet għall- glucose fid- demm Prodotti mediċinali parenterali li fihom maltose jistgħu jinterferixxu mar- riżultati ta ’ moniters tal - glucose fid- demm li jużaw strippi għat- testijiet bi glucose dehydrogenase pyrroloquinolinequinone (GDH- PQQ).
The GDH-PQQ based glucose monitoring systems may react with the maltose present in ORENCIA, resulting in falsely elevated blood glucose readings on the day of infusion.
Is- sistemi ta ’ monitoraġġ tal- glucose ibbażata fuq GDH- PQQ tista ’ tirreaġġixxi mal - maltose preżenti f’ ORENCIA, bil- konsegwenza li tirriżulta f’ qari falz ta ’ livell għoli ta ’ glucose fid - demm dak inhar ta ’ l- infużjoni.
When receiving ORENCIA, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
Meta jieħdu ORENCIA, pazjenti li għandhom bżonn monitoraġġ tal - glucose fid- demm iridu jiġu avżati biex jikkonsidraw metodi li ma jagħmlux reazzjoni ma ’ maltose, bħal metodi ta ’ testijiet ibbażati fuq glucose dehydrogenase nicotine adenine dinucleotide (GDH - NAD), glucose oxidase jew glucose hexokinase.
Patients on controlled sodium diet This medicinal product contains 1.5 mmol (or 34.5 mg) sodium per maximum dose of 4 vials (0.375 mmol or 8.625 mg sodium per vial).
4 Pazjenti fuq dieta li tikkontrolla t- teħid ta ’ sodium Dan il- prodott mediċinali fih 1. 5 mmol (jew 34. 5 mg) ta ’ sodium f’ kull doża massima ta ’ 4 kunjetti (0. 375 mmol jew 8. 625 mg ta ’ sodium f’ kull kunjett).
To be taken into consideration when treating patients on a controlled sodium diet.
Dawk il- pazjenti li qegħdin fuq dieta ta 'kontroll tas- sodium għandhom jikkunsidraw dan.
Combination with TNF blocking agents There is limited experience with the use of abatacept in combination with TNF blocking agents (see section 5.1).
Kombinazzjoni ma ’ sustanzi li jimblokkaw TNF Hemm esperjenza limitata dwar l- użu ta ’ abatacept f’ kombinazzjoni ma ’ sustanzi li jimblokkaw TNF (ara sezzjoni 5. 1).
While TNF blocking agents did not influence abatacept clearance, in placebo-controlled clinical trials, patients receiving concomitant treatment with abatacept and TNF blocking agents experienced more infections and serious infections than patients treated with only TNF blocking agents.
Waqt li sustanzi li jimblokkaw TNF ma affettwawx l- eliminazzjoni ta ’ abatacept, fi provi kliniċi ikkontrollati bi plaċebo, pazjenti li rċevew trattament b’ abatacept flimkien ma ’ sustanzi li jimblokka TNF esperjenzaw iktar infezzjonijiet u infezzjonijiet serji minn dawk il- pazjenti li ngħataw sustanzi li jimblokkaw TNF biss.
Therefore, concurrent therapy with ORENCIA and a TNF blocking agent is not recommended.
Għalhekk terapija ta ’ ORENCIA mogħtija flimkien ma ’ sustanzi li jimblokka TNF m’ hijiex rakkomandata.
Combination with other medicinal products Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Kombinazzjoni ma ’ prodotti mediċinali oħra Analiżi farmakokinetika tal- popolazzjoni ma wriet l- ebda effett ta ’ methotrexate, NSAIDs u kortikosterojdi fuq l- eliminazzjoni ta ’ abatacept (ara sezzjoni 5. 2).
No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Ma ġew identifikati punti sostanzjali ta ’ sigurtà bl- użu ta ’ abatacept meta mogħti flimkien ma ’ sulfasalazine, hydroxychloroquine jew leflunomide.
See section 4.4 regarding combination with other medicinal products that affect the immune system and with vaccinations.
Ara sezzjoni 4. 4 fuq il- kombinazzjoni ma ’ prodotti mediċinali oħra li jaffetwaw is- sistema immuni u ma ’ tilqim.
There are no adequate data from use of abatacept in pregnant women.
M’ hemmx biżżejjed tagħrif dwar l- użu ta ’ abatacept f’ nisa tqal.
In embryo-foetal development studies no undesirable effects were observed at doses up to 29-fold a human 10 mg/ kg dose based on AUC.
Fi żvilupp embrijo- fetali ma ġie osservat l- ebda effett mhux mitieq f’ dożi sa 29 darba d- doża fl- umani ta ’ 10 mg/ kg fuq il- bażi ta ’ AUC.
In a pre- and postnatal development study limited changes in immune function were observed at 11-fold a human 10 mg/ kg dose based on AUC (see section 5.3).
Fi studju fuq l- iżvilupp qabel u wara t- twelid, ġie osservata tibdil limitat fuq il- funzjoni ta ’ l - immunità f’ dożi li hija 11- il darba d- doża fl- umani ta ’ 10 mg/ kg fuq il- bażi ta’ AUC (ara sezzjoni 5. 3).
ORENCIA should not be used in pregnant women unless clearly necessary.
ORENCIA ma jistax jintuża f’ nisa tqal sakemm dan ma jkunx assolutament meħtieġ.
Women of child-bearing potential should use effective contraception during treatment with ORENCIA and up to 14 weeks after the last dose of abatacept treatment.
Nisa b’ potenzjal li jkollhom it- tfal iridu jużaw kontraċezzjoni effettiva waqt it- trattament b’ ORENCIA u sa 14- il ġimgħa wara l- aħħar doża tat- trattament b’ abatacept.
Use during lactation Abatacept has been shown to be present in rat milk.
Użu waqt it- treddigħ Intwera li abatacept huwa preżenti fil- ħalib tal- ġrieden.
It is not known whether abatacept is excreted in human milk.
M’ huwiex magħruf jekk abatacept joħroġx fil - ħalib uman.
Women should not breastfeed while treated with ORENCIA and for up to 14 weeks after the last dose of abatacept treatment.
Nisa m’ għandhomx ireddgħu waqt trattament b’ ORENCIA u għal 14- il ġimgħa wara l - aħħar doża ta ’ trattament b’ abatacept.
Fertility Formal studies of the potential effect of ORENCIA on human fertility have not been conducted.
Fertilità Ma sarux studji formali fuq l- effetti potenzjali ta ’ ORENCIA fuq il- fertilità umana.
In rats, abatacept had no undesirable effects on male or female fertility (see section 5.3).
Fil- firien, abatacept ma kellu l- ebda effett mhux mixtieq fuq il- fertilità ta ’ l- irġiel jew tan- nisa (ara sezzjoni 5. 3).
Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (1,955 patients with abatacept, 989 with placebo).
Abatacept ġie studjat f’ pazjenti b’ artrite tar- rewmatiżmu attiva fi provi kliniċi kkontrollati bi plaċebo (1, 955 pazjent b’ abatacept, 989 bi plaċebo).
The trials had either a double-blind, placebo-controlled period of 6 months (258 patients with abatacept, 133 with placebo) or 1 year (1,697 patients with abatacept, 856 with placebo).
Il- provi kellhom jew perijodu ta ’ 6 xhur double- blind, kkontrollati bi plaċebo (258 pazjent b’ abatacept, 133 bi plaċebo) jew sena (1, 697 pazjent b’ abatacept, 856 bil- plaċebo).
Most patients in these trials were taking methotrexate (81.9% with abatacept, 83.3% with placebo).
Il- biċċa l- kbira ta ’ dawn il- pazjenti f’ dawn il- provi kienu qed jieħdu methotrexate (81. 9% ma ’ abatacept, 83. 3% ma ’ plaċebo).
Other concomitant medications included:
Mediċini oħra li kienu qed jittieħdu fl- istess waqt inkludew:
NSAIDs (83.9% with abatacept, 85.1% with placebo); systemic corticosteroids (74.7% with abatacept, 75.8% with placebo); non-biological DMARD therapy, most commonly chloroquine/ hydroxychloroquine, leflunomide and/ or sulfasalazine (26.9% with abatacept, 32.1% with placebo); TNF blocking agents, mainly etanercept (9.4% with abatacept, 12.3% with placebo); and anakinra (1.1% with abatacept, 1.6% with placebo).
5 ma’ abatacept, 75. 8% ma ’ plaċebo); terapija DMARD mhux bijoloġika, l- aktar komuni chloroquine/ hydroxychloroquine, leflunomide u/ jew sulfasalazine (26. 9% ma ’ abatacept, 32. 1% ma ’ plaċebo); sustanzi li jimblokkaw TNF, b’ mod partikolari etanercept (9. 4% ma’ abatacept, 12. 3% ma ’ plaċebo); u anakinra (1. 1% ma ’ abatacept, 1. 6% ma ’ plaċebo).
In placebo-controlled clinical trials with abatacept, adverse drug reactions (ADRs) were reported in 52.2% of abatacept-treated patients and 46.1% of placebo-treated patients.
Fi provi kliniċi b’ abatacept ikkontrollati bi plaċebo, effetti avversi tal- mediċina (ADRs) ġew irrapportati fi 52. 2% tal- pazjenti ttrattati b’ abatacept u f’ 46. 1% tal- pazjenti ttrattati bi plaċebo.
The most frequently reported adverse drug reactions (≥ 5%) among abatacept-treated patients were headache and nausea.
L- aktar effett avversi li ġie rrapportat (≥ 5%) fost pazjenti ttrattati b’ abatacept kienu uġigħ ta ’ ras u nawsja.
5 The proportion of patients who discontinued treatment due to ADRs was 3.4% for abatacept-treated patients and 2.2% for placebo-treated patients.
Il - proporzjon ta ’ pazjenti li ma komplewx it- trattament minħabba ADRs kien ta ’ 3. 4% għal pazjenti ttrattati b’ abatacept u 2. 2% għal dawk ittrattati bi plaċebo.
Listed in Table 2 are adverse drug reactions that occurred with greater frequency (difference > 0.2%) in abatacept-treated patients than in placebo-treated patients.
Fit- Tabella 2 hemm elenkat ir- reazzjonijiet avversi tal- mediċina li seħħew bi frekwenza ogħla (differenza > 0. 2%) f’ pazjenti ttrattati b’ abatacept milli f’ dawk ittrattati bi plaċebo.
The list is presented by system organ class and frequency, using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Il- lista hija preżentata skond is- sistema u frekwenza ta ’ klassifika ta ’ l- organi, permezz ta ’ dawn il- kategoriji: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1, 000 sa < 1/ 100); rari (≥ 1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F' kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżlin skond is- serjetà tagħhom.
Undesirable Effects in Placebo-Controlled Trials
Effetti Mhux Mixtieqa fi Provi Kliniċi Kkontrollati bi Plaċebo
Common Blood pressure increased, liver function test abnormal (including transaminases increased) Uncommon Blood pressure decreased, weight increased
Komuni Żieda fil- pressjoni tad- demm, anormalità fit - testijiet tal- funzjoni tal- fwied (inkluż żieda fit - transaminażi) Mhux komuni Tnaqqis fil- pressjoni tad- demm, żieda fil- piż
Tachycardia, bradycardia, palpitations
Takikardja, bradikardja, palpitazzjonijiet
Thrombocytopenia, leukopenia
Tromboċitopenja, lewkopenja
Very Common Common Uncommon
Komuni ħafna Komuni Mhux komuni
Headache Dizziness Paraesthesia
Uġigħ ta 'ras Sturdament Paraesteżija
Eye disorders
Disturbi fil- għajnejn