qanastek/EMEA-V3 huggingface dataset:
The Physician Information Pack should contain the following key elements: • The Summary of Product Characteristics • Dose calculation, preparation of infusion and infusion rate • Risk of serious infections o The product should not be given to patients with active or suspected infection o The product may lessen signs and symptoms of acute infection delaying the diagnosis • Serious infusion reaction and their management • Serious hypersensitivity reactions and their management • Risk of gastrointestinal perforations especially in patients with history of diverticulitis or intestinal ulcerations • Reporting of serious adverse drug reactions • The Patient Information Packs (to be given to patients by healthcare professionals)
Il- Pakkett ta ’ Informazzjoni għat- Tabib għandu jkun fih il- punti prinċipali li ġejjin: • Is- Sommarju tal- Karatteristiċi tal- Prodott • Kalkulazzjoni tad- doża, preparazzjoni ta ’ l- infużjoni u r- rata ta ’ l- infużjoni • Riskju ta ’ infezzjonijiet serji o Il- prodott m’ għandux jingħata lill- pazjenti b’ infezzjoni attiva jew b’ suspett ta ’ infezzjoni o Il- prodott jista ’ jnaqqas is- sinjali u s- sintomi ta ’ infezzjoni akuta u jittardja d- dijanjosi • Reazzjonijiet għall- infużjoni serji u l- immaniġjar tagħhom • Reazzjonijiet ta ’ sensittività eċċessiva serji u l- immaniġjar tagħhom • Riskju ta ’ perforazzjoni gastro- intestinali speċjalment f’ pazjenti b’ passat ta ’ divertikulite jew ulċerazzjoni intestinali • Rapport ta ’ reazzjonijiet avversi serji tal- mediċina • Il- Pakketti ta ’ Informazzjoni għall- Pazjent (sabiex jingħataw lill- pazjenti minn professjonisti fil- qasam tas- saħħa)
The Nurse Information Pack should contain the following key elements: • Prevention of medical errors and infusion reactions o Preparation of infusion o Infusion rate • Monitoring of the patient for infusion reactions • Reporting of serious adverse drug reactions
Il- Pakkett ta ’ Informazzjoni għall- infermier għandu jkun fih il- punti prinċipali li ġejjin: • Prevenzjoni ta ’ żbalji mediċi u reazzjonijiet għall- infużjoni o Preparazzjoni ta ’ l- infużjoni o Rata ta ’ l- infużjoni • Sorveljanza tal- pazjent għal reazzjonijiet għall- infużjoni • Rapport ta ’ reazzjonijiet avversi serji tal- mediċina
The Patient Information Pack should contain the following key elements: • Patient Information Leaflet • Patient Alert Card
Il- Pakkett ta ’ Informazzjoni għall- pazjent għandu jkun fih il- punti prinċipali li ġejjin: • Fuljett ta ’ Tagħrif għall- Pazjent • Biljett ta ’ Twissija għall- Pazjent
What is RoActemra?
X’ inhu RoActemra?
RoActemra is a concentrate that is made up into a solution for infusion (drip into a vein).
RoActemra huwa sustanza konċentrata li tinħall f’ soluzzjoni għall- infużjoni (dripp fil- vina).
It contains the active substance tocilizumab.
Fiha s - sustanza attiva tocilizumab.
What is RoActemra used for?
Għal xiex jintuża RoActemra?
RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (an immune system disease causing inflammation of the joints).
RoActemra jintuża biex jittratta adulti bl- artrite rewmatojde attiva moderata għal severa (marda tas - sistema immunitarja li tikkawża infjammazzjoni fil- ġogi).
It is used in combination with methotrexate (another medicine used in rheumatoid arthritis) in patients who have not responded adequately to or who could not tolerate other treatments, including conventional medicines for rheumatoid arthritis (such as methotrexate) or tumour necrosis factor (TNF) blockers.
Jintuża flimkien ma ’ methotrexate (mediċina oħra użata għall- artrite rewmatojde) fil- pazjenti li ma jkunux irrispondew b’ mod adegwat għal jew li ma jkunux jittolleraw trattamenti oħra, inkluż mediċini konvenzjonali għall- artrite rewmatojde (bħall- methotrexate) jew għall- imblokkaturi tal- fattur tan- nekrożi tat- tumuri (TNF).
RoActemra can be used on its own in patients who cannot take methotrexate.
RoActemra jista ’ jintuża waħdu f’ pazjenti li ma jistgħux jieħdu methotrexate.
How is RoActemra used?
Kif jintuża RoActemra?
Treatment with RoActemra should be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
It- trattament b’ RoActemra għandu jinbeda minn tabib bl- esperjenza fid- dijanjożi u t- trattament tal - artrite rewmatojde.
RoActemra is given once every four weeks as an infusion lasting an hour.
RoActemra jingħata darba kull erba ’ ġimgħat bħala infużjoni li ddum siegħa.
The recommended dose is 8 mg per kilogram body weight.
Id- doża rakkomandata hija ta ’ 8 mg għal kull kilogramma piż tal- ġisem.
The minimum dose is 480 mg, and doses above 1,200 mg have not been tested.
Id- doża minima hija 480 mg, u ma ġewx ittestjati dożi ogħla minn 1, 200 mg.
The dose of RoActemra or methotrexate may need to be adjusted or treatment interrupted in patients who develop liver or blood problems.
Id- doża ta ’ RoActemra jew methotrexate jista ’ jkollha bżonn tiġi aġġustata jew jista ’ jkun hemm bżonn li t- trattament jiġi interrott f’ pazjenti li jiżviluppaw problemi fil- fwied jew fid- demm.
Doctors should monitor the kidneys carefully in patients with moderate or severe kidney problems.
It- tobba għandhom jimmonitorjaw il- kliewi bir- reqqa f’ pazjenti bi problemi tal- kliewi moderati jew severi.
Patients who receive RoActemra should be given the special alert card that summarises the safety information about the medicine.
Il- pazjenti li jingħataw RoActemra għandhom jingħataw il- kard ta ’ twissija speċjali li tagħti tagħrif fil - qosor dwar is- sigurtà tal- mediċina.
How does RoActemra work?
Kif jaħdem RoActemra?
The active substance in RoActemra, tocilizumab, is a monoclonal antibody.
Is- sustanza attiva f’ RoActemra, tocilizumab, hija antikorp monoklonali.
Tocilizumab has been designed to bind to the receptor for a messenger molecule (cytokine) in the body called interleukin-6.
Tocilizumab ġie ddisinjat biex jeħel mar- riċettur għall- molekulu messaġġier (ċitokina) fil- ġisem magħruf bħala interleukin- 6.
This messenger is involved in causing inflammation and is found at high levels in patients with rheumatoid arthritis.
Dan il- messaġġier huwa involut fl - ikkawżar ta ’ infjammazzjoni u jinstab f’ livelli għoljin f’ pazjenti bl- artrite rewmatojde.
By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of rheumatoid arthritis.
Billi jimpedixxi interleukin- 6 milli jeħel mar- riċetturi tiegħu, tocilizumab inaqqas l- infjammazzjoni u sintomi oħrajn tal- artrite rewmatorjde.
How has RoActemra been studied?
Kif ġie studjat RoActemra?
The effects of RoActemra were first tested in experimental models before being studied in humans.
L- effetti ta ’ RoActemra għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ’ ġew studjati fil - bnedmin.
RoActemra has been studied in five main studies involving a total of over 4,000 adults with moderate to severe rheumatoid arthritis.
RoActemra ġie studjat f’ ħames studji ewlenin li fihom b’ kollox ħadu sehem aktar minn 4, 000 adult b’ artrite rewmatojde minn moderata għal severa.
Four of the studies compared RoActemra with placebo (a dummy treatment).
Erba ’ mill- istudji qabblu RoActemra ma ’ plaċebo (trattament finta).
In three of these, the medicines were given as an add-on to failing treatment with methotrexate or other conventional rheumatoid arthritis medicines in a total of over 3,000 patients.
Fi tlieta minn dawn, il- mediċini ngħataw bħala żieda ma ’ trattament li ma jkunx qed jaħdem b’ methotrexate jew b’ mediċini konvenzjonali oħra għall- artrite rewmatojde f’ total ta ’ iktar minn 3, 000 pazjent.
In the fourth study, the medicines were given in combination with methotrexate in 498 patients who had an inadequate response to previous treatment with TNF blockers.
Fir- raba ’ studju, il- mediċini ngħataw flimkien ma ’ methotrexate f’ 498 pazjent li kellhom rispons inadegwat għat- trattament preċedenti b’ imblokkaturi ta ’ TNF.
The fifth study compared RoActemra given on its own with methotrexate in a total of 673 patients.
Il- ħames studju qabbel RoActemra mogħti waħdu ma ’ methotrexate f’ total ta ’ 673 pazjent.
In all five studies, the main measure of effectiveness was the number of patients who had responded to treatment after six months.
Fil- ħames studji, il- mezz ewlieni tal- kejl tal- effikaċja kien l- għadd ta ’ pazjenti li rrispondew għat- trattament wara sitt xhur.
A response was defined as a reduction in symptom scores of 20% or more as measured using a standard scale for rheumatoid arthritis.
Rispons kien definit bħala tnaqqis fil- punteġġ tas- sintomi ta ’ 20% jew iktar kif imkejjel bl- użu ta ’ skala standard għall- artrite rewmatojde.
A total of 2,439 patients from these studies went on to enter two studies looking at the long-term effects of RoActemra treatment.
Imbagħad, total ta ’ 2, 439 pazjent minn dawn l- istudji ddaħħlu f’ żewġ studji li ħarsu lejn l- effetti fit- tul tat- trattament b’ RoActemra.
What benefit has RoActemra shown during the studies?
Liema benefiċċji wera RoActemra matul dawn l- istudji?
RoActemra was more effective than the comparator medicines at reducing the symptoms of rheumatoid arthritis.
RoActemra kien iktar effettiv mill- mediċini li tqabbel magħhom fit- tnaqqis tas- sintomi tal- artrite rewmatojde.
In the three studies of patients with an inadequate response to methotrexate or other conventional rheumatoid arthritis treatments, patients adding RoActemra at the approved dose were around four times more likely to respond to treatment than those adding placebo.
Fit- tliet studji ta ’ pazjenti b’ rispons inadegwat għal methotrexate jew mediċina oħra konvenzjonali għat- trattament tal- artrite rewmatojde, il- pazjenti li żdidilhom RoActemra fid- doża approvata kellhom probabilità ta ’ erba ’ darbiet iktar li jirrispondu għat- trattament minn dawk li żdidilhom il- plaċebo.
In the study of patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around nine times more likely to respond than those receiving placebo.
Fl - istudju ta ’ pazjenti li kellhom rispons inadegwat għall- imblokkaturi TNF, il- pazjenti li ngħataw RoActemra ma ’ methotrexate kellhom probabilità ta ’ madwar disa ’ darbiet iktar li jirrispondu minn dawk li ngħataw il- plaċebo.
The fifth study showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.
Il- ħames studju wera li pazjenti li ngħataw RoActemra waħdu kellhom probabilità ikbar li jirrispondu minn dawk li kienu qed jieħdu methotrexate waħdu.
The long-term studies showed that the response to RoActemra is maintained for at least a year.
L- istudju dwar l- effetti fit- tul urew li r- rispons għal RoActemra jiġi mantnut għal tal- anqas sena.
What is the risk associated with RoActemra?
X’ inhu r- riskju assoċjat ma ’ RoActemra?
The most common side effect with RoActemra (seen in more than 1 patient in 10) is upper respiratory tract infections (colds).
L- iktar effett sekondarju komuni ma ’ RoActemra (li deher f’ iktar minn pazjent wieħed minn kull 10) huwa infezzjonjiet fin- naħa ta ’ fuq tas- sistema respiratorja (irjiħat).
For the full list of all side effects reported with RoActemra, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati ma ’ RoActemra, ara l- Fuljett ta ’ Tagħrif.
RoActemra should not be used in people who may be hypersensitive (allergic) to tocilizumab or any of the other ingredients.
RoActemra m’ għandux jintuża f’ persuni li jistgħu jkunu allerġiċi għal tocilizumab jew għal xi sustanza oħra tiegħu.
It must not be used in patients who have an active, severe infection.
M’ għandux jintuża f’ pazjenti li jkollhom infezzjoni akuta, severa.
Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis (a disease affecting the gut) or diabetes.
It- tobba għandhom jissorveljaw lill- pazjenti bir- reqqa għal sinjali ta ’ infezzjoni waqt it- trattament, u għandhom jippreskrivu RoActemra b’ kawtela f’ pazjenti li jkollhom infezzjonijiet rikorrenti fit- tul, jew mard li jżid ir- riskju ta ’ infezzjonijiet, bħad- divertikulite (marda li taffettwa l- imsaren) jew id- dijabete.
Why has RoActemra been approved?
Għaliex ġie approvat RoActemra?
The Committee for Medicinal Products for Human Use (CHMP) decided that RoActemra’ s benefits are greater than its risks, in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs or TNF antagonists, or as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ RoActemra huma ikbar mir- riskji tiegħu, f’ kombinazzjoni ma ’ methotrexate, għat- trattament ta ’ artrite rewmatojde moderata jew severa fil- pazjenti adulti jew li rrispondew b’ mod inadegwat għal, jew li kienu intolleranti għal, terapija preċedenti ma ’ mediċina waħda jew iktar mill- mediċini anti- rewmatiċi jew antagonisti tat- TNF, jew bħala monoterapija fil- każ ta ’ intolleranza għal methotrexate jew fejn it - trattament imkompli ma ’ methotrexate ma jkunx xieraq.
The Committee recommended that RoActemra be given marketing authorisation.
Il- Kumitat irrakkommanda li RoActemra jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of RoActemra?
Liema miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ RoActemra?
The company that makes RoActemra will supply packs containing information for doctors, nurses and patients prior to the medicine ’ s launch in each Member State.
Il- kumpanija li tagħmel RoActemra se tipprovdi pakketti bit- tagħrif għal tobba, infermiera u pazjenti qabel ma tqiegħed il- mediċina fis- suq ta ’ kull Stat Membru.
These packs will include information on RoActemra’ s safety and on how it should be given to patients.
Dawn il- pakketti se jkun fihom tagħrif dwar is- sigurtà ta ’ RoActemra u fuq kif għandu jingħata lill- pazjenti.
Other information about RoActemra:
Informazzjoni oħra dwar RoActemra:
The European Commission granted a marketing authorisation valid throughout the European Union for RoActemra to Roche Registration Limited on 16 January 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal RoActemra lil Roche Registration Limited fid- 16 ta ’ Jannar 2009.
2/ 3 The full EPAR for RoActemra can be found here.
2/ 3 L- EPAR sħiħ għal RoActemra jista ’ jiġi kkonsultat hawn.
EU Number
Numru ta ’ Proċedura ta ’ l- EU
Route of Administration
Użu għal ġol- vini
Package size
kunjett wieħed
Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use
Konċentrat għal soluzzjoni għall - infużjoni
Vial (glass) Vial (glass) Vial (glass) Vial (glass) Vial (glass) Vial (glass)
Kunjett (ħġieġ)
1 vial 4 vials 1 vial 4 vials 1 vial 4 vials
4 kunjetti
RoActemra 20 mg/ ml concentrate for solution for infusion.
RoActemra, 20 mg/ ml, konċentrat għal soluzzjoni għall- infużjoni.
Each ml concentrate contains 20 mg tocilizumab*.
Kull ml ta ’ konċentrat fih 20 mg tocilizumab *.
Each vial contains 80 mg of tocilizumab* in 4 ml (20 mg/ ml).
Kull kunjett fih 80 mg ta ’ tocilizumab * f’ 4 ml (20 mg/ ml).
Each vial contains 200 mg of tocilizumab* in 10 ml (20 mg/ ml).
Kull kunjett fih 200 mg ta ’ tocilizumab * f’ 10 ml (20 mg/ ml).
Each vial contains 400 mg of tocilizumab* in 20 ml (20 mg/ ml).
Kull kunjett fih 400 mg ta ’ tocilizumab * f’ 20 ml (20 mg/ ml).
*humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
* antikorp monoklonali IgG1 umanizzat kontra r- riċettur ta ’ interleukin- 6 (IL- 6) uman magħmul f’ ċelluli tal- ovarji tal- ħamster Ċiniż (CHO) permezz ta ’ teknoloġija rikombinanti tad- DNA.
Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Kull kunjett ta ’ 80 mg fih 0. 10 mmol (2. 21 mg) sodium.
Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Kull kunjett ta ’ 200 mg fih 0. 20 mmol (4. 43 mg) sodium.
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
Kull kunjett ta ’ 400 mg fih 0. 39 mmol (8. 85 mg) sodium.
Concentrate for solution for infusion (sterile concentrate).
Konċentrat għal soluzzjoni għall- infużjoni (konċentrat sterili).
Clear to opalescent, colourless to pale yellow solution.
Soluzzjoni ċara jew tkanġi, bla kulur jew isfar ċar.
RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
RoActemra, f’ taħlita ma ’ methotrexate (MTX), huwa indikat għal kura ta ’ artrite rewmatojde attiva (RA) moderata jew qawwija f’ pazjenti adulti li jew ma rrispondewx tajjeb, jew inkella kienu intolleranti, għal terapija preċedenti b’ wieħed jew aktar mill- mediċini kontra r- rewmatiżmu li jimmodifikaw il- marda (DMARDs) jew antagonisti tal- fattur nekrotiku tat- tumur (TNF).
In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
F’ dawn il - pazjenti, f’ każ ta ’ intolleranza għal MTX jew fejn kura kontinwa b’ MTX mhux xierqa, RoActemra jista ’ jingħata bħala monoterapija.
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA.
Il- kura għandha tinbeda minn professjonisti tal- kura tas- saħħa b’ esperjenza fid- dijanjosi u l- kura ta ’ RA.
Patients treated with RoActemra should be given the Patient Alert Card.
Pazjenti kkurati b’ RoActemra għandhom jingħataw il- Biljett ta ’ Twissija għall- Pazjenti.
Posology The recommended posology is 8 mg/ kg body weight, but no lower than 480 mg, given once every four weeks.
Pożoloġija Il- pożoloġija rrakkomandata hija ta ’ 8 mg/ kg piż tal- ġisem, iżda mhux inqas minn 480 mg li tingħata darba kull erba ’ ġimgħat.
Doses above 1.2 g have not been evaluated in clinical studies (see section 5.1).
Dożi ’ l fuq minn 1. 2 g ma ġewx ivvalutati fl- istudji kliniċi (ara sezzjoni 5. 1).
2 Dose adjustments due to laboratory abnormalities (see section 4.4).
2 Aġġustament fid- doża minħabba anormalitajiet tal- laboratorju (ara sezzjoni 4. 4).
• Liver enzyme abnormalities
• Anormalitajiet ta ’ l- enżima tal- fwied
Laboratory Value
Valur tal -
> 1 to 3 x Upper Dose modify concomitant MTX if appropriate Limit of Normal For persistent increases in this range, reduce RoActemra dose to 4 mg/ kg or (ULN) interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised Restart with 4 mg/ kg or 8 mg/ kg, as clinically appropriate
Jekk meħtieġ biddel id- doża ta ’ MTX li qed jingħata fl- istess waqt Għal żidiet persistenti f’ din il- firxa, naqqas id- doża ta ’ RoActemra għal 4 mg/ kg jew waqqaf RoActemra sakemm alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) jerġgħu lura għan- normal
> 3 to 5 x ULN
> 3 sa 5 x ULN
Interrupt RoActemra dosing until < 3 x ULN
Waqqaf l- għoti ta ’ RoActemra sakemm < 3 x ULN
by When values reach < 3 x ULN, resume RoActemra at 4 mg/ kg or 8 mg/ kg dose
(ikkonfermat minn ittestjar ripetut, ara sezzjoni 4. 4).
repeat testing, see For persistent increases > 3 x ULN, discontinue RoActemra section 4.4).
Meta l- valuri jilħqu < 3 x ULN, erġa ’ ibda RoActemra b’ doża ta ’ 4 mg/ kg jew 8 mg/ kg Għal żidiet persistenti ta ’ > 3 x ULN, waqqaf RoActemra
Discontinue RoActemra
Waqqaf RoActemra
• Low absolute neutrophil count (ANC)
• Għadd assolut ta ’ newtrofili baxx (ANC)
Laboratory Value (cells x 109/ l)
Valur tal -
Maintain dose
Żomm id- doża
ANC 0.5 to 1
ANC 0. 5 sa 1
Interrupt RoActemra dosing
Waqqaf għal xi żmien l- għoti ta ’ RoActemra
When ANC increases > 1 x 109/ l resume RoActemra at 4 mg/ kg and increase to 8 mg/ kg as clinically appropriate
Meta l- ANC jiżdied għal > 1 x 109 / l erġa ’ ibda RoActemra b’ 4 mg/ kg u żid sa 8 mg/ kg kif klinikament xieraq
• Low platelet count
• Għadd ta ’ plejtlits baxx
Laboratory Value (cells x 103/ μ l)
Valur tal -
50 to 100
50 sa 100
When platelet count > 100 x 103/ μ l resume RoActemra at 4 mg/ kg and increase to 8 mg/ kg as clinically appropriate
Meta l- għadd tal- plejtlits jilħaq > 100 x 103 / μl erġa ’ ibda RoActemra b’ 4 mg/ kg u żid sa 8 mg/ kg kif klinikament xieraq
< 50 Discontinue RoActemra
< 50 Waqqaf RoActemra
Special populations Paediatric patients:
Popolazzjonijiet speċjali
RoActemra is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.
RoActemra mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed tagħrif dwar is- sigurtà u l- effikaċja.
Elderly patients:
3 Pazjenti anzjani:
No dose adjustment is required in patients aged 65 years and older.
Mhux neċessarju li jsir aġġustament fid- doża f’ pazjenti ta ’ età 65 sena jew aktar.
No dose adjustment is required in patients with mild renal impairment.
Mhux neċessarju li jsir aġġustament fid- doża f’ pazjenti b’ indeboliment tal - kiewi ħafif.
Renal
RoActemra ma kienx studjat f’ pazjenti b’ indebolimenti tal- kliewi moderat sa sever (ara sezzjoni 5. 2).
3 function should be monitored closely in these patients.
F’ dawn il- pazjenti l- funzjoni tal- kliewi għandha tiġi sorveljata mill- viċin.
RoActemra has not been studied in patients with hepatic impairment.
RoActemra ma ġiex studjat f’ pazjenti b’ indeboliment tal- fwied.
Therefore, no dose recommendations can be made.
Għalhekk, ma jistgħux isiru rakkomandazzjonijiet tad- doża.
Method of administration After dilution, RoActemra should be administered as an intravenous infusion over 1 hour.
Metodu ta ’ l- għoti Wara li jiġi dilwit, RoActemra għandu jingħata bħala infużjoni fil- vini fuq medda ta ’ siegħa.
RoActemra should be diluted to a final volume of 100 ml with sterile, non-pyrogenic sodium chloride 9 mg/ ml (0.9%) solution for injection using aseptic technique.
RoActemra għandu jiġi dilwit għall- volum finali ta ’ 100 ml b’ soluzzjoni għall- injezzjoni sterili u mhux piroġenika ta ’ sodium chloride 9 mg/ ml (0. 9%) bl- użu ta ’ teknika asettika.
For further information on dilution prior to administration, see section 6.6.
Għal aktar targħif dwar id- dilwazzjoni qabel l- għoti, ara sezzjoni 6. 6.
Active, severe infections (see section 4.4).
Infezzjonijiet attivi severi (ara sezzjoni 4. 4).
Infections RoActemra treatment should not be initiated in patients with active infections (see section 4.3).
Infezzjonijiet Kura b’ RoActemra m’ għandhiex tinbeda f’ pazjenti li għandhom infezzjonijiet attivi (ara sezzjoni 4. 3).
Administration of RoActemra should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.8).
Jekk pazjent jiżviluppa infezzjoni serja, l- għoti ta ’ RoActemra irid jitwaqqaf sakemm l- infezzjoni tiġi kkontrollata (ara sezzjoni 4. 8).
Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurring or chronic infections or with underlying conditions (e. g. diverticulitis, diabetes) which may predispose patients to infections.
Professjonisti tal- kura tas- saħħa għandhom jużaw kawtela meta jikkunsidraw l- użu ta ’ RoActemra f’ pazjenti b’ passat ta ’ infezzjonijiet li jerġu jitfaċċaw jew kroniċi jew jekk għandhom xi kundizzjonijiet (eż. divertikulite, dijabete) li jistgħu jippredisponu lill- pazjenti għal infezzjonijiet.
Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments for moderate to severe RA as signs and symptoms of acute inflammation may be lessened, associated with suppression of the acute phase reaction.
Huwa rrakkomandat li f’ pazjenti li jirċievu kura bijoloġika għall- RA moderata jew severa jkun hemm viġilanza sabiex infezzjonijiet serji jinstabu malajr kemm jista ’ jkun għax b’ hekk is- sinjali u s- sintomi ta ’ infjammazzjoni akuta jkunu jistgħu jitnaqqsu, b’ rabta mas- soppressjoni tar- reazzjoni fil- fażi akuta.
The effects of tocilizumab on C-reactive protein (CRP), neutrophils and signs and symptoms of infection should be considered when evaluating a patient for a potential infection.
Meta pazjent jiġi vvalutat għall- infezzjoni potenzjali, għandhom jiġu kkunsidrati l- effetti ta ’ tocilizumab fuq il- proteina Ċ- reattiva (CRP), newtrofili u sinjali u sintomi ta ’ infezzjoni.
Patients should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Il- pazjenti għandhom jiġu mwissija sabiex jikkuntattjaw lill- professjonist tal- kura tas- saħħa tagħhom immedjatament meta jidhru xi sintomi li jissuġġerixxu infezzjoni, sabiex tiġi assigurata valutazzjoni rapida u kura xierqa.
Tuberculosis As recommended for other biological treatments in RA, patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Tuberkulosi Kif irrakkomandat għall- kuri bijoloġici oħra ta ’ RA, l- pazjenti għandhom jiġu ttestjat għal tuberkulosi (TB) li mhux attiva qabel tinbeda terapija b’ RoActemra.
Patients with latent TB should be treated with standard anti-mycobacterial therapy before initiating RoActemra.
Pazjenti b’ TB li mhux attiva għandhom jiġu kkurati b’ terapija standàrd kontra l- mikobatterja qabel jinbeda RoActemra.
Complications of diverticulitis Events of diverticular perforations as complications of diverticulitis have been reported uncommonly with RoActemra (see section 4.8).
Kumplikazzjonijiet ta ’ divertikulite Ġrajjiet ta ’ perforazzjonijiet divertikulari bħala kumplikazzjonijiet ta ’ divertikulite ġew irrapportati b’ mod mhux komuni b’ RoActemra (ara sezzjoni 4. 8).
RoActemra should be used with caution in patients with previous history of intestinal ulceration or diverticulitis.
RoActemra għandu jintuża b’ kawtela f’ pazjenti bi storja preċedenti ta ’ ulċerazzjoni intestinali jew divertikulite.
Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/ or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Pazjenti li jippreżentaw sintomi li juru potenzjalità ta ’ kumplikazzjoni ta ’ divertikulite, bħal uġigħ addominali, emorraġija u/ jew bidla mhux spjegata fl- abitudni tal- ippurgar bid- deni għandhom jiġu vvalutati immedjatament għal identifikazzjoni bikrija ta ’ divertikulite li tista ’ tkun assoċjata ma ’ perforazzjoni gastrointestinali.
Hypersensitivity reactions Serious hypersensitivity reactions have been reported in association with infusion of RoActemra in approximately 0.3% of patients (see section 4.8).
4 Reazzjonijiet ta ’ sensittività eċċessiva Reazzjonijiet serji ta ’ sensittività eċċessiva ġew irrapportati b’ rabta ma ’ infużjoni ta ’ RoActemra f’ madwar 0. 3% tal- pazjenti (ara sezzjoni 4. 8).
Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during administration of RoActemra.
Il- kura adatta għandha tkun disponibbli għall- użu fil - pront f’ każ ta ’ reazzjonijiet anafilattiċi waqt it- teħid ta ’ RoActemra.
4 Active hepatic disease and hepatic impairment Treatment with RoActemra, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases (see section 4.8).
Mard attiv tal- fwied u indeboliment tal- fwied Kura b’ RoActemra, speċjalment meta jingħata flimkien ma ’ MTX, tista ’ tkun assoċjata ma ’ żidiet fit - transaminases tal- fwied (ara sezzjoni 4. 8).
Therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment, as the safety of RoActemra in these patients has not been adequately studied (see section 4.2).
Għalhekk, għandha tintuża kawtela meta tiġi kkunsidrata l - kura ta ’ pazjenti b’ mard attiv tal- fwied jew b’ indeboliment tal- fwied, peress li s- sigurtà ta ’ RoActemra ma ġietx studjata b’ mod xieraq f’ dawn il- pazjenti (ara sezzjoni 4. 2).
Hepatic transaminase elevations In clinical trials, transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with RoActemra treatment, without progression to hepatic injury (see section 4.8).
Żidiet fil- livelli ta ’ transaminase tal- fwied Fi studji kliniċi, ġew irrapportati b’ mod komuni żidiet temporanji jew intermittenti ħfief u moderati fil- livelli ta ’ transaminases tal- fwied ikkawżati mill- kura b’ RoActemra, mingħajr progressjoni għal ħsara fil- fwied (ara sezzjoni 4. 8).
An increased frequency of these elevations was observed when potentially hepatotoxic drugs (e. g.
Żjieda fil- frekwenza ta ’ dawn iż- żidiet ġiet osservata meta mediċini potenzjalment epatotossiċi (eż.
MTX) were used in combination with RoActemra.
MTX) intużaw flimkien ma ’ RoActemra.
Caution should be exercised when considering initiation of RoActemra treatment in patients with elevated ALT or AST > 1.5 x ULN.
Għandu jkun hemm kawtela meta jiġi kkunsidrat li tinbeda l- kura b’ RoActemra f’ pazjenti b’ livelli għolja ta ’ ALT jew AST ta ’ > 1. 5x ULN.
In patients with baseline ALT or AST > 5 x ULN, treatment is not recommended.
F’ pazjenti b’ linja bażi ta ’ ALT jew AST ta ’ > 5x ULN, il - kura mhijiex irrakkomandata.
ALT and AST levels should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Il- livelli ta ’ ALT u AST għandhom jiġu sorveljati kull 4 sa 8 ġimgħat għall- ewwel 6 xhur ta ’ kura, segwit b’ sorveljanza kull 12- il ġimgħa minn hemm ’ l quddiem.
For recommended modifications based on transaminases see section 4.2.
Għall- modifikazzjonijiet irrakkomandati bbażati fuq tansaminases ara sezzjoni 4. 2.
For ALT or AST elevations > 3– 5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted.
Għal żidiet ta ’ ALT jew AST ta ’ > 3– 5 x ULN, ikkonfermati minn ittestjar ripetut, kura b’ RoActemra għandha titwaqqaf.
Once the patient ’ s hepatic transaminases are below 3 x ULN, treatment with RoActemra may recommence at 4 or 8 mg/ kg.
Ladarba it - transaminases tal- fwied tal- pazjent huma taħt 3 x ULN, kura b’ RoActemra tista ’ tinbeda mill- ġdid b’ 4 jew 8 mg/ kg.
Haematological abnormalities Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/ kg in combination with MTX (see section 4.8).
Anormalitajiet ematoloġiċi Tnaqqis fl- għadd ta ’ newtrofili u plejtlits seħħ wara kura b’ tocilizumab 8 mg/ kg flimkien ma ’ MTX (ara sezzjoni 4. 8).
There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist.
Jista ’ jkun hemm żjieda fir- riskju ta ’ newtropenija f’ pazjenti li kienu kkurati minn qabel b’ antagonist ta ’ TNF.
Caution should be exercised when considering initiation of RoActemra treatment in patients with a low neutrophil or platelet count (i. e.
Għandu jkun hemm kawtela meta jiġi kkunsidrat il- bidu ta ’ kura b’ RoActemra f’ pazjenti b’ għadd baxx ta ’ newtrofili jew plejtlits (i. e.
ANC < 2 x 109/ l or platelet count below 100 x 103/ μ l).
ANC ta ’ < 2 x 109 / l jew għadd ta ’ plejtlits taħt 100 x 103 / μl).
In patients with an ANC < 0.5 x 109/ l or a platelet count < 50 x 103/ μ l treatment is not recommended.
F’ pazjenti b’ ANC ta ’ < 0. 5 x 109 / l jew għadd ta ’ plejtlits ta ’ < 50 x 103 / μl il- kura mhijiex irrakkomandata.
Neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
In- newtrofili u l- plejtlits għandhom jiġu ċċekkjati minn 4 sa 8 ġimgħat wara li tinbeda l- kura u minn hemm ’ l quddiem skond il- prattika klinika standàrd.
For recommended dose modifications based on ANC and platelet counts, see section 4.2.
Għall- modifikazzjonijet irrakkomandati fid- doża bbażati fuq ANC u l- għadd tal- plejtlits, ara sezzjoni 4. 2.
Lipid parameters Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with tocilizumab (see section 4.8).
Parametri ta ’ lipidi F’ pazjenti kkurati b’ tocilizumab ġew osservati żidiet fil- parametri tal- lipidi inkluż kolesterol totali, lipoproteina ta ’ densità baxxa (LDL), lipoproteina ta ’ densità għolja (HDL) u trigliċeridi (ara sezzjoni 4. 8).
In the majority of patients, there was no increase in atherogenic indices, and elevations in total cholesterol responded to treatment with lipid lowering agents.
Fil- maġġoranza tal- pazjenti, ma kien hemm l- ebda żjieda fl- indiċi ateroġeniċi, u żidiet fil - kolesterol totali irrispondew għall- kura b’ sustanzi li jbaxxu l- lipidi.
Assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Il- parametri tal- lipidi għandhom jiġu vvalutati minn 4 sa 8 gimgħat wara li tinbeda t- terapija b’ RoActemra.
Patients should be managed according to local clinical guidelines for management of hyperlipidaemia.
Il- pazjenti għandhom jiġu mmaniġġati skond il- linji gwida kliniċi lokali għall - immaniġġar tal- iperlipidimja.
Neurological disorders Physicians should be vigilant for symptoms potentially indicative of new-onset central demyelinating disorders.
Disturbi newrologiċi It- tobba għandhom joqgħodu attenti għal sintomi li potenzjalment juru bidu ġdid ta ’ mard li jikkawża t- telf ta ’ majelin ċentrali.
The potential for central demyelination with RoActemra is currently unknown.
Fil- preżent il- potenzjal ta ’ RoActemrali jikkawża telf ta ’ majelin ċentrali mhux magħruf.
Malignancy The risk of malignancy is increased in patients with RA.
5 Tumuri malinni Ir- riskju ta ’ tumuri malinni jiżdied f’ pazjenti b’ RA.
Immunomodulatory medicinal products may increase the risk of malignancy.
Prodotti mediċinali immunomodulatorji jistgħu jżidu r- riskju ta ’ tumuri malinni.
Vaccinations Live and live attenuated vaccines should not be given concurrently with RoActemra as clinical safety has not been established.
Tilqim Vaċċini ħajjin u dawk bil- virus attenwat m’ għandhomx jingħataw flimkien ma ’ RoActemra peress li s - sigurtà klinika ma ġietx stabbilita.
5 Cardiovascular risk RA patients have an increased risk for cardiovascular disorders and should have risk factors (e. g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Riskju kardjovaskulari Pazjenti b’ RA għandhom riskju ogħla ta ’ mard kardjovaskulari u l- fatturi ta ’ riskju (eż. pressjoni għolja, iperlipidimja) għandhom ikunu mmaniġġati bħala parti mill- kura regolari.
Combination with TNF antagonists There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA.
Taħlita ma ’ antagonisti ta ’ TNF M’ hemmx esperjenza bl- użu ta ’ RoActemra ma ’ anagonisti ta ’ TNF jew kuri bijoloġiċi oħra għal RA.
RoActemra is not recommended for use with other biological agents.
RoActemramhux irrakkomandat għall- użu ma ’ sustanzi bijologiċi oħra.
Sodium This medicinal product contains 1.17 mmol (or 26.55 mg) sodium per maximum dose of 1200 mg.
Sodium Dan il- prodott mediċinali fih 1. 17 mmol (jew 26. 55 mg) ta ’ sodium f’ kull doża massima ta ’ 1200 mg.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jiġi kkunsidrat minn pazjenti fuq dieta ta ’ sodium kkontrollat.
Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i. e. essentially ‘ sodium free’.
Dożi taħt 1025 mg ta ’ dan il- prodott mediċinali fihom inqas minn 1 mmol ta ’ sodium (23 mg), i. e. essenzjalment ‘ bla sodium ’.
Concomitant administration of a single dose of 10 mg/ kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
L- għoti ta ’ doża waħda ta ’ 10 mg/ kg tocilizumab flimkien ma ’ 10- 25 mg MTX darba fil- ġimgħa ma kellu l- ebda effett ta ’ sinifikanza klinika fuq l- espożizzjoni għal MTX.
Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids on tocilizumab clearance.
Analiżi tal- farmakokinetika tal- popolazzjoni ma sabet l- ebda effett ta ’ MTX, mediċini anti - infjammatorji mhux sterojdi (NSAIDs) jew kortikosterojdi fuq it- tneħħija ta ’ tocilizumab.
The expression of hepatic CYP450 enzymes is suppressed by the cytokines, such as IL-6, that stimulate chronic inflammation.
L- espressjoni tal- enżimi CYP450 tal- fwied hija soppressa miċ- ċitokini, bħal IL- 6, li jistimulaw infjammazzjoni kronika.
Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced.
Għaldaqstant, l- espressjoni ta ’ CYP450 tista ’ titreġġa ’ lura meta tinbeda terapija qawwija b’ inibitur ta ’ ċitokin bħal tocilizumab.
In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19, and CYP3A4 enzyme expression.
Studji in vitro b’ epatoċiti umani kkolturati wrew li IL- 6 ikkawża tnaqqis fl- espressjoni tal- enżimi CYP1A2, CYP2C9, CYP2C19, u CYP3A4.
Tocilizumab normalises expression of these enzymes.
Tocilizumab jinnormalizza l- espressjoni ta ’ dawn l- enżimi.
When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2, 2C9 or 2C19 (e. g. atorvastatin, calcium channel blockers, theophylline, warfarin, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Meta tinbeda jew titwaqqaf terapija b’ tocilizumab, pazjenti li jieħdu prodotti mediċinali li huma aġġustati individwalment u huma mmetabolizzati permezz ta ’ CYP450 3A4, 1A2, 2C9 jew 2C19 (eż. atorvastatin, sustanzi li jibblukkaw il- kanal tal- kalċju, theophylline, warfarin, phenytoin, ciclosporin, jew benzodiazepines) għandhom jiġu immonitorjati peress li d- dożi jista ’ jkollhom bżonn li jiżdiedu biex jinżamm l- effett terapewtiku.
Given its long elimination half-life (t1/ 2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Minħabba l- half- life (t1/ 2) ta ’ l- eleminazzjoni twila tiegħu, l- effett ta ’ tocilizumab fuq l- attività ta ’ l- enżima CYP450 jista ’ jippersisti għal ħafna ġimgħat wara li titwaqqaf il- kura.
Pregnancy There are no adequate data from the use of tocilizumab in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ tocilizumab waqt it- tqala.
A study in animals has shown an increased risk of spontaneous abortion/ embryo-foetal death at a high dose (see section 5.3).
Studji fuq bhejjem urew riskju akbar ta ’ abort spontanju/ mewt tal- embriju– fetu b’ doża kbira (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Mhux magħruf ir - riskju li jista ’ jkun hemm fuq il- bnedmin.
Women of childbearing potential must use effective contraception during and up to 6 months after treatment.
Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt u sa 6 xhur wara l- kura.
RoActemra should not be used during pregnancy unless clearly necessary.
RoActemra m’ għandux jintuża waqt it- tqala jekk mhux verament neċċessarju.
Lactation It is unknown whether tocilizumab is excreted in human breast milk.
Treddigħ Mhux magħruf jekk tocilizumab joħroġx fil- ħalib tas- sider uman.
The excretion of tocilizumab in milk has not been studied in animals.
It- tneħħija ta ’ tocilizumab fil- ħalib ma ġietx studjata fil- bhejjem.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with RoActemra should be made taking into account the benefit of breast-feeding to the child and the benefit of RoActemra therapy to the woman.
6 titkompliex/ tinqatax it- terapija b’ RoActemra għandha tittieħed wara li jiġi meqjus il- benefiċċju tat - treddigħ għat- tarbija u l- benefiċċju tat- terapija b’ RoActemra għall- omm.
However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Madankollu, peress li sturdament kien irrapportat b’ mod komuni, pazjenti li jkollhom esperjenza ta ’ din ir- reazzjoni avversa għandhom jiġu avżati biex ma jsuqux jew iħaddmu magni qabel jgħaddi l- effett.
A total of 3,778 patients received at least one dose of RoActremra 4 mg/ kg or 8 mg/ kg.
Total ta ’ 3, 778 pazjent irċieva mill- anqas doża waħda ta ’ RoActemra 4 mg/ kg jew 8 mg/ kg.
The adverse drug reactions (ADRs) presented in Table 1 are based on the safety of tocilizumab studied in 4 placebo-controlled studies (studies II, III, IV and V) and 1 MTX-controlled study (study I) (see section 5.1).
Ir- reazzjonijiet avversi tal- mediċina (ADRs) ippreżentati f’ Tabella 1 huma bbażati fuq is- sigurtà ta ’ tocilizumab studjati f’ erba ’ studji kkontrollati bil- plaċebo (studji II, III, IV u V) u studju 1 ikkontrollat b’ MTX (studju I) (ara sezzjoni 5. 1).
In these studies, 774 patients received tocilizumab 4 mg/ kg in combination with MTX, 1,582 patients received tocilizumab 8 mg/ kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/ kg monotherapy.
F’ dawn l- istudji, 774 pazjent irċevew tocilizumab 4 mg/ kg flimkien ma ’ MTX, 1, 582 pazjent irċevew tocilizumab 8 mg/ kg flimkien ma ’ MTX / DMARDs oħra u 288 pazjent irċevew monoterapija ta ’ tocilizumab 8 mg/ kg.
The long-term open label extension studies included 2,562 patients who received tocilizumab 8 mg/ kg with or without DMARDs.
L- istudji ta ’ estensjoni open label fit- tul inkludew 2, 562 pazjent li irċevew tocilizumab 8 mg/ kg flimkien ma ’ jew mingħajr DMARDs.
The total exposure in the long-term safety analysis was 3,685 patient years.
L- espożizzjoni totali fl- analiżi ta ’ sigurtà fit- tul kienet ta ’ 3, 685 sena ta ’ pazjenti.
The most commonly reported ADRs (occurring in ≥ 5% of patients treated with tocilizumab monotherapy or in combination with DMARDs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
L- ADRs li l- aktar li ġew irrapportati b’ mod komuni (iseħħu f’ ≥ 5% tal- pazjenti kkurati b’ monoterapija ta ’ tocilizumab jew flimkien ma ’ DMARDs) kienu infezzjonijiet fl- apparat respiratorju ta ’ fuq, nażofarinġite, uġigħ ta ’ ras, pressjoni għolja u żjieda fl- ALT.
The ADRs listed in Table 1 are presented by system organ class and frequency categories, defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10) or uncommon (≥ 1/ 1,000 to < 1/ 100).
L- ADRs imniżżlin f’ Tabella 1 huma ppreżentati skond is- sistema tal- klassifika tal- organi u l- kategoriji ta ’ frekwenza, definiti bl- użu tal- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10); komuni (> 1/ 100 sa < 1/ 10) jew mhux komuni (> 1/ 1, 000 sa < 1/ 100).
Table 1.
7 Tabella 1.
Summary of ADRs occurring in patients with RA receiving tocilizumab as monotherapy or in combination with MTX or other DMARDs
Sommarju ta ’ ADRs li jseħħu f’ pazjenti b’ RA li jirċievu kura ta ’ tocilizumab bħala monoterapija jew flimkien ma ’ MTX jew DMARDs oħra
Common Common
Komuni Ħafna Komuni
Infections and infestations
klassifika tal - organi Infezzjonijiet u infestazzjonijiet
Upper respiratory tract infections
Infezzjonijiet fl - apparat respiratorju ta ’ fuq
Cellulitis, Pneumonia, Oral herpes simplex, Herpes zoster
Ċellulite, Pulmonite, Herpes simplex tal- ħalq, Herpes zoster
Diverticulitis
Divertikulite
Mouth ulceration, Gastritis
Ulċeri fil- ħalq, Gastrite
Rash, Pruritus
Raxx, Ħakk
Headache, Dizziness
Uġigħ ta ’ ras, Sturdament
Hepatic transaminases increased
Żjieda ta ’ transaminases epatiċi
Total bilirubin increased
Żjieda ta ’ bilirubina totali
Vascular disorders
Disturbi vaskulari Disturbi tad- demm u tas- sistema limfatika
Leukopenia, Neutropenia
Pressjoni għolja Lewkopenja, Newtropenja
Hypercholesterolaemia
Iperkolesterolimja
Conjunctivitis
Infezzjonijiet
7 Infections In the controlled studies the rate of all infections reported with tocilizumab 8 mg/ kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 patient years in the placebo plus DMARD group.
Fl- istudji kkontrollati, ir- rata tal- infezzjonijiet kollha rrapportati b’ tocilizumab 8 mg/ kg flimkien ma ’ kura b’ DMARDs kienet ta ’ 127 ġrajja għal kull 100 sena ta ’ pazjenti meta mqabbla ma ’ 112- il ġrajja għal kull 100 sena ta ’ pazjenti fil- grupp ta ’ plaċebo flimkien ma ’ DMARDs.
In the long-term open label extension studies, the rate of infections with RoActemra plus DMARDs was 116 events per 100 patient years exposure.
Fl- istudji ta ’ estensjoni open label fit- tul, ir- rata ta ’ infezzjonijiet b’ RoActemra flimkien ma ’ DMARDs kienet ta ’ 116- il ġrajja għal kull 100 sena ta ’ espożizzjoni ta ’ pazjenti.
In controlled clinical studies, the rate of serious infections with tocilizumab 8 mg/ kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
Fl- istudji kliniċi kkontrollati, ir- rata ta ’ infezzjonijiet serji b’ tocilizumab 8 mg/ kg flimkien ma ’ DMARDs kienet ta ’ 5. 3 ġrajjiet għal kull 100 sena ta ’ espożizzjoni ta ’ pazjenti meta mqabbla ma ’ 3. 9 ġrajjiet għal kull 100 sena ta ’ espożizzjoni ta ’ pazjenti fil- grupp ta ’ plaċebo ma ’ DMARDs.
In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the tocilizumab group and 1.5 events per 100 patient years of exposure in the MTX group.
Fl- istudju tal- monoterapija, ir- rata ta ’ infezzjonijiet serji kienet ta ’ 3. 6 ġrajjiet għal kull 100 sena ta ’ espożizzjoni ta ’ pazjenti fil- grupp ta ’ tocilizumab u 1. 5 ġrajjiet għal kull 100 sena ta ’ espożizzjoni ta ’ pazjenti fil - grupp ta ’ MTX.
In the long-term safety population (core and extension studies), the rate of serious infections observed with tocilizumab plus DMARD treatment was 3.9 events per 100 patient years exposure.
Fi studji ta ’ popolazzjoni (studji proprji u ta ’ estensjoni) għas- sigurtà fit- tul, ir- rata ta ’ infezzjonijiet serji li ġew osservati b’ tocilizumab flimkien ma ’ kura b’ DMARDs kienet ta ’ 3. 9 ġrajjiet għal kull 100 sena ta ’ espożizzjoni ta ’ pazjenti.
Reported serious infections included pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Infezzjonijiet serji li ġew irrapportati kienu jinkludu il- pulmonite, iċ - ċellulite, il- herpes zoster, il- gastroenterite, id- divertikulite, is- sepsi u l- artrite batterika.
Serious infections were rarely fatal.
Infezzjonijiet serji kienu rarament fatali.
Cases of opportunistic infections have been reported.
Ġew irrapportati każijiet ta ’ infezzjonijiet opportunistiċi.
Complications of diverticulitis During the six month controlled trials, complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess have been reported uncommonly with tocilizumab therapy.
Kumplikazzjonijiet ta ’ divertikulite Waqt il- provi kkontrollati ta ’ sitt xhur il- kumplikazzjonijiet ta ’ divertikulite li- ġew irrapportati b’ mod mhux komuni b’ terapija ta ’ tocilizumab kienu jinkludu peritonite ġeneralizzata bil- materja, perforazzjoni gastro- intestinali tal- parti t’ isfel, fistli u axxessi.
Infusion reactions Adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/ kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
8 Reazzjonijiet tal- infużjoni Ġrajjiet avversi assoċjati mal- infużjoni (ċerti ġrajjiet iseħħu waqt l- infużjoni jew fi żmien 24 siegħa mill- infużjoni) ġew irrapportati minn 6. 9% tal- pazjenti fil- grupp ta ’ tocilizumab 8 mg/ kg flimkien ma ’ DMARDs u f’ 5. 1% tal- pazjenti fil- grupp ta ’ plaċebo ma ’ DMARDs.