qanastek/EMEA-V3 huggingface dataset:
Antibodies to infliximab cannot always be detected in serum samples.
Antikorpi għal infliximab mhux dejjem jistgħu jkunu jitkejlu fil- kampjuni tas- serum.
If serious reactions occur, symptomatic treatment must be given and further Remicade infusions must not be administered (see section 4.8:
Jekk iseħħu reazzjonijiet serji, għandu jingħata trattament sintomatiku u m’ għandhomx jingħataw iktar infużjonijiet ta ’ Remicade.
"Immunogenicity").
(ara sezzjoni 4. 8: “ Immunoġeniċità ”).
In clinical studies, delayed hypersensitivity reactions have been reported.
Fi studji kliniċi, reazzjonijiet ta ’ sensittività eċċessiva ttardjata kienu rrappurtati.
Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval.
Tagħrif disponibbli jindika żieda fir- riskju ta ’ sensittività eċċessiva ttardjata ma ’ żieda fl- intervall mingħajr Remicade.
Advise patients to seek immediate medical advice if they experience any delayed adverse event (see section 4.8: “ Delayed hypersensitivity”).
Agħti parir lill- pazjenti biex ifittxu parir mediku mill- ewwel jekk ikollhom xi effett avvers ittardjat (ara sezzjoni 4. 8: “ Sensittività eċċessiva ttardjata ”).
If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Jekk pazjenti jerġgħu jiġu trattati wara żmien twil, għandhom ikunu osservati mill- qrib għal sinjali u sintomi ta ’ sensittività eċċessiva ttardjata.
Infections Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Remicade.
Infezzjonijiet Il- pazjenti għandhom jiġu osservati mill- qrib għal infezzjonijiet li jinkludu tuberkulożi qabel, waqt jew wara trattament b ’ Remicade.
Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Peress li t- tneħħija ta’ infliximab jista ’ jdum sa sitt xhur, l - osservazzjoni għandha titkompla matul dan iż- żmien.
Further treatment with Remicade must not be given if a patient develops a serious infection or sepsis.
Aktar trattament b ’ Remicade m’ għandux jingħata jekk il- pazjent jiżviluppa infezzjoni serja jew sepsis.
Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Għandha ssir attenzjoni meta jkun meqjus l- użu ta ’ Remicade f’ pazjenti b’ infezzjoni kronika jew passat ta ’ infezzjonijiet li jirkadu, inkluż l- użu fl- istess ħin ta ’ terapija immunsoppressiva.
Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Il- pazjenti għandhom jingħataw parir dwar jew biex l- esponiment għall- fatturi li jistgħu jżidu r- riskju għal infezzjonijiet kif jixraq.
Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Fattur alfa tan- necrożi tat- tumur (TNFα) jikkontrolla l- infjammazzjoni u jimmodula ir- rispons immuni taċ- ċelluli.
Experimental data show that TNFα is essential for the clearing of intracellular infections.
Tagħrif sperimentali juri li TNFα huwa essenzjali biex jitneħħew infezzjonijiet fiċ- ċelluli.
Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab.
Esperjenza klinika turi li d- difiża tal- host kontra l- infezzjonijiet tiddgħajjef f’ xi pazjenti li jingħataw infliximab.
It should be noted that suppression of TNFα may mask symptoms of infection such as fever.
Wieħed irid jinnota li t- tnaqqis ta ’ TNFα jista ’ wkoll jaħbi sintomi ta ’ infezzjoni bħad- deni.
Early recognition of atypical clinical presentations of serious infections is critical in order to minimize delays in diagnosis and treatment.
Ir - rikonoxximent minn kmieni ta ’ preżentazzjonijiet kliniċi mhux tipiċi ta ’ infezzjonijiet serji huwa kritiku sabiex jitnaqqsu d- dewmien tad- dijanjosi u l- kura.
6 Patients taking TNF-blockers are more susceptible to serious infections.
6 Pazjenti li qed jieħdu inblukkaturi ta ’ TNF huma aktar suxxettibbli għal infezzjonijiet serji.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal infections, and other opportunistic infections have been observed in patients treated with infliximab.
Tuberkulożi, infezzjonijiet ta ’ batteri, li inkludu sepsis u pulmonite, infezzjonijiet invażivi tal- moffa, u infezzjonijiet opportunistiċi oħra dehru f’ pazjenti li ngħataw infliximab.
Some of these infections have been fatal.
Uħud minn dawn l - infezzjonijiet kienu fatali.
Patients who develop a new infection while undergoing treatment with Remicade, should be monitored closely and undergo a complete diagnostic evaluation.
Pazjenti li jiżviluppaw infezzjoni ġdida waqt li jkunu qed jieħdu kura b’ Remicade, għandhom ikunu monitorati mill- qrib u tittieħdilhom evalwazzjoni dijanjostika kompleta.
Administration of Remicade should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
L- għotja ta ’ Remicade għandha titwaqqaf jekk pazjent toħroġlu infezzjoni ġdida serja jew sepsi, u terapija kontra l- mikrobi jew kontra l- fungi għandha tinbeda hekk kif jixraq sakemm l- infezzjoni tkun ikkontrollata.
For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade therapy.
Għal pazjenti li għexu jew marru f’ reġjuni fejn infezzjonijiet tal- fungi bħal ħistoplażmożi, kokkidjodomikożi, jew blastomikożi huma endemiċi, il- benefiċċji u r- riskji tal- kura b’ Remicade għandhom jitqiesu bir- reqqa qabel tinbeda it- terapija b’ Remicade.
There have been reports of active tuberculosis in patients receiving Remicade.
Kien hemm rapporti ta ’ tuberkulożi attiva f’ pazjenti li kienu qed jirċievu Remicade.
It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
Ta ’ min jinnota li fil- maġġoranza ta ’ dawn ir- rapporti it- tuberkulożi kienet ekstra- pulmonari, u ħarġet bħala marda lokalizzata jew mifruxa.
Opportunistic infections reported in patients on Remicade have included, but are not limited to pneumocystosis, histoplasmosis, cytomegalovirus infection, atypical mycobacterial infections, listeriosis and aspergillosis.
Infezzjonijiet opportunistiċi rappurtati f’ pazjenti fuq Remicade kienu jinkludu, iżda ma kienux limitati għal pnewmoċistożi, istoplażmożi, infezzjoni b’ ċitomegalovajrus, infezzjonijiet mikobatteriċi mhux tipiċi, listerjożi u asperġillożi.
In clinical studies, infections have been reported more frequently in paediatric patient populations than in adult patient populations (see section 4.8).
Fi studji kliniċi, infezzjonijiet kienu rrappurtati b’ mod aktar frekwenti f’ pazjenti tfal milli f’ popolazzjonijiet ta ’ pazjenti adulti (ara sezzjoni 4. 8).
Before starting treatment with Remicade, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
Qabel ma jibdew it- trattament b’ Remicade, il- pazjenti kollha għandhom ikunu eżaminati għat - tuberkulożi kemm attiva kif ukoll mhux attiva (‘ moħbija ’).
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/ or current immunosuppressive therapy.
Dan l- eżami għandu jinkludi l- passat mediku fid- dettall mal- passat personali ta ’ tuberkulożi jew kuntatt li seta ’ kien hemm qabel ma ’ tuberkulożi u terapija immunosoppressiva qabel u/ jew fil- preżent.
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Testijiet ta ’ stħarriġ adattati, jiġifieri test tal- ġilda bit- tuberkulin u raġġi- X tas- sider għandhom isiru fuq il- pazjenti kollha (rakkomandazzjonijiet lokali jistgħu jkunu applikati).
It is recommended that the conduct of these tests should be recorded in the patient’ s alert card.
Huwa rakkomandat illi meta dawn it- testijiet isiru jitniżżlu fuq il- biljett ta ’ avviż tal- pazjent.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Min jordnhom għandu jżomm f’ moħħu r- riskju li r - riżultati tat- test tal- ġilda bit- tuberkulin jistgħu jkunu negattivi foloz, l- aktar f’ pazjenti li huma morda ħafna jew immunosoppressi.
If active tuberculosis is diagnosed, Remicade therapy must not be initiated (see section 4.3).
Jekk issir dijanjosi ta ’ tuberkulożi attiva, it- terapija b’ Remicade m’ għandiex tinbeda (ara sezzjoni 4. 3).
If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Jekk ikun maħsub li hemm tuberkulożi moħbija, tabib espert fil- kura tat- tuberkulożi għandu jiġi konsultat.
In all situations described below, the benefit/ risk balance of Remicade therapy should be very carefully considered.
Fis- sitwazzjonijiet kollha deskritti hawn taħt, il- bilanċ bejn il- benefiċċju/ riskju tat- terapija b’ Remicade għandu jitqies bir- reqqa.
If inactive (‘ latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Remicade, and in accordance with local recommendations.
Jekk issir dijanjosi ta ’ tuberkulożi mhux attiva (‘ moħbija ’) terapija għal- kontra t- tuberkulożi għandha tinbeda b’ mod profilattiku qabel ma ’ jinbeda Remicade, u skond ir- rakkomandazzjonijiet lokali.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of Remicade.
Pazjenti li għandhom ħafna fatturi ta riskju jew fatturi ta ’ riskju sinifikanti għal tuberkulożi u jkollhom test negattiv għal tuberkulożi moħbija, terapija kontra t- tuberkulożi għandha titqies qabel ma jinbeda Remicade.
Use of anti-tuberculosis therapy should also be considered before the initiation of Remicade in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
L- użu ta ’ terapija kontra t- tuberkulożi għandha titqies ukoll qabel jinbeda Remicade f’ pazjenti li fil - passat kellhom tuberkulożi moħbija jew attiva li ma jistax ikun konfermat jekk ħadux kors xieraq.
All patients should be informed to seek medical advice if signs/ symptoms suggestive of tuberculosis (e. g. persistent cough, wasting/ weight loss, low-grade fever) appear during or after Remicade treatment.
Il- pazjenti kollha għandhom ikunu nfurmati sabiex ifittxu parir mediku jekk is- sinjali/ sintomi jindikaw tuberkulożi (eż sogħla persistenti, jgħolbu/ jitilfu l- piż, deni ħafif) jidhru meta jew wara t- trattament b’ Remicade.
Patients with fistulising Crohn’ s disease with acute suppurative fistulas must not initiate Remicade therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
7 Pazjenti bil- marda ta ’ Crohn li tkun fistulizzanti b’ fistli akuti li jdennu m’ għandhomx jibdew terapija b’ Remicade sakemm wieħed jeskludi l- għajn ta ’ infezzjoni li jista ’ jkun hemm, b’ mod speċifiku qrada (ara sezzjoni 4. 3)
7 Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Remicade, who are chronic carriers of this virus.
Lattivazzjoni mill- ġdid ta ’ epatite B Lattivazzjoni mill- ġdid ta ’ epatite B seħħet f’ pazjenti li kienu qed jirċievu antagonist tat- TNF inkluż Remicade li jġorru b’ mod kroniku dan il- vajrus.
Some cases have had fatal outcome.
Xi każijiet wasslu għall- mewt.
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Remicade therapy.
Pazjenti li għandhom riskju ta ’ infezzjoni b’ HBV għandhom jiġu evalwati għall- evidenza ta ’ infezzjoni b’ HBV minn qabel qabel ma tinbeda t- terapija b’ Remicade.
Carriers of HBV who require treatment with Remicade should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Dawk li jkollhom l- HBV li jkollhom bżonn kura b’ Remicade għandhom jinżammu taħt osservazzjoni mill- qrib għal sinjali u sintomi ta ’ infezzjoni b’ HBV attiva waqt it- terapija u għal ħafna xhur wara li tintemm it- terapija.
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
M’ hemx dejta xierqa fuq il- kura ta ’ pazjenti li jkollhom l- HBV b’ terapija anti- virali flimkien ma ’ antagonist- TNF sabiex tiġi evitata r - riattivazzjoni ta ’ l- HBV.
In patients who develop HBV reactivation, Remicade should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
F’ pazjenti li jiżviluppaw ir- riattivazzjoni ta ’ l- HBV, Remicade għandu jitwaqqaf u terapija effettiva anti- virali tinbeda flimkien ma ’ kura ta ’ support.
Hepatobiliary events Very rare cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Remicade.
Każijiet rari ħafna ta ’ suffejra u ta ’ epatite mhux infettiva, xi wħud b’ karatteristiċi ta ’ epatite awto - immuni, dehru waqt l- esperjenza ta ’ wara li tqiegħed fis- suq Remicade.
Isolated cases of liver failure resulting in liver transplantation or death have occurred.
Seħħew każijiet iżolati ta ’ insuffiċjenza tal- fwied li wasslu għal trapjant tal- fwied jew mewt.
Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury.
Pazjenti li jkollhom sinjali jew sintomi ta ’ funzjoni ħażina tal- swied għandhom ikunu evalwati għall- evidenza ta ’ ħsara fil- fwied.
If jaundice and/ or ALT elevations ≥ 5 times the upper limit of normal develop(s), Remicade should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Jekk ikun (j) tiżviluppa( w) s- suffejra u/ jew l- ALT jogħlew għal ≥ 5 darbiet il- limitu ta ’ fuq in- normali, Remicade għandu jitwaqqaf, u jsir stħarriġ dwar l- anormalità.
Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections were seen in clinical studies with concurrent use of anakinra and another TNFα - blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Amministrazzjoni f’ daqqa ta ’ inibitur ta ’ TNF- alfa u anakinra Dehru infezzjonijiet serji waqt studji kliniċi bl- użu fl- istess ħin ta ’ anakinra ma ’ aġent ieħor li jinblokka TNFα, etanercept, u ma nkiseb l- ebda benefiċċju ieħor meta mqabbel ma ’ etanercept waħdu.
Because of the nature of the adverse events seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα -blocking agents.
Minħabba n- natura tal- każijiet avversi li dehru bis- soluzzjoni ta ’ etanercept u terapija b’ anakinra, effetti tossiċi simili jistgħu joħorġu meta anakinra jingħata flimkien ma ’ aġenti oħra li jinblokkaw TNFα.
Therefore, the combination of Remicade and anakinra is not recommended.
Għalhekk, mhux rakkomandat li Remicade u anakinra jingħataw flimkien.
Vaccinations No data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines in patients receiving anti-TNF therapy.
Tilqim M’ hemmx tagħrif dwar ir- rispons għat- tilqima b’ vaċċini ħajjin jew fuq il- passaġġ sekondarju ta ’ l - infezzjoni mill- vaċċini ħajjin f’ pazjenti li qed jirċievu terapija anti- TNF.
It is recommended that live vaccines not be given concurrently.
Huwa rakkomandat li vaċċini ħajjin ma jingħatawx flimkien.
It is recommended that paediatric Crohn’ s disease patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.
Huwa rrikkmandat li pazjenti tfal bil- marda ta ’ Crohn, jekk ikun possibli, jingħataw it- tilqim kollha li jkun imisshom jieħdu skond il- linji gwida tat- tilqim kurrenti qabel tinbeda t- terapija b’ Remicade.
Autoimmune processes The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Proċessi awtoimmuni In- nuqqas relattiv ta ’ TNFα minħabba t- terapija anti- TNF jista ’ jwassal għall- bidu ta ’ proċess awtoimmuni.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, further treatment with Remicade must not be given (see section 4.8: “ Anti-nuclear antibodies (ANA)/ Double- stranded DNA (dsDNA) antibodies”).
Jekk pazjent jiżviluppa sintomi bħal ta ’ sindromu tal- lupus wara trattament b’ Remicade, u jiġi posittiv għall- antikorpi kontra double stranded DNA, m’ għandux jingħata iktar trattament b’ Remicade (ara sezzjoni 4. 8: “ Antikorpi antinuklejari (ANA) / antikorpi kontra Double- stranded DNA (dsDNA ”)
Neurological events Infliximab and other agents that inhibit TNFα have been associated in rare cases with optic neuritis, seizure and new onset or exacerbation of clinical symptoms and/ or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Każijiet newroloġiċi Infliximab u sustanzi oħra li jinibixxu TNFα kienu assoċjati f’ każijiet rari ma ’ newrite ottika, aċċessjonijiet u bidu jew taħrix ta ’ sintomi kliniċi u/ jew evidenza radjografika ta ’ mard li jneħħi l - majelin tas- sistema nervuża ċentrali, li jinkludi sklerożi multipla u mard li jneħħi l- majelin tas- sistema periferali, inkluża s- sindrome Guillain- Barré.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade therapy.
F’ pazjenti li diġà kellhom mard li jneħħi l- majelin jew li żviluppawh ftit qabel, il- benefiċċji u r- riskji tat- trattament b’ Remicade għandhom jiġu meqjusa bir - reqqa qabel ma tinbeda t- terapija b’ Remicade.
Malignancies and lymphoproliferative disorders In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Tumuri malinni u mard limfoproliferattiv Fil- partijiet kontrollati ta ’ l- istudji kliniċi ta ’ aġenti li jinblukkaw TNF, aktar każijiet ta ’ tumuri inkluża limfoma dehru fost pazjenti li kienu qed jingħataw inblukkatur ta ’ TNF imqabbla ma ’ pazjenti fuq il- kontroll.
During clinical studies of Remicade across all approved indications the incidence of lymphoma in Remicade-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Waqt studji kliniċi ta ’ Remicade bl- idikazzjonijiet kollha li ġew approvati l- inċidenza ta ’ limfoma f’ pazjenti ttrattati b’ Remicade kienet ogħla milli mistennija fil- popolazzjoni ġenerali, iżda 8 limfoma seħħet b’ mod rari.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with longstanding, highly active, inflammatory disease, which complicates the risk estimation.
Minbarra hekk, hemm riskju akbar ta ’ limfoma fis- sottofond f’ pazjenti b’ artrite rewmatika b’ marda li tkun ilha, attiva ħafna, infjammatorja, li tikkomplika l- istima tar- riskju.
8 In an exploratory clinical study evaluating the use of Remicade in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in Remicade-treated patients compared with control patients.
Fi studju klinika ta ’ stħarriġ li kienet tevalwa l- użu ta ’ Remicade f’ pazjenti b’ mard tal- pulmun ostruttiv kroniku (COPD) moderat għal sever, kien hemm aktar tumuri rrappurtati bil- pazjenti kkurati b’ Remicade meta mqabbla ma ’ pazjenti fuq il- kontroll.
All patients had a history of heavy smoking.
Il- pazjenti kollha fil- passat kienu jpejpu ħafna.
Caution should be exercised in considering treatment of patients with increased risk for malignancy due to heavy smoking.
Għandu jkun hemm kawtela meta jkun qed jitqies it- trattament ta ’ pazjenti li jkollhom riskju ogħla ta ’ tumuri minħabba li kienu jpejpu ħafna.
With the current knowledge, a risk for the development of lymphomas or other malignancies in patients treated with a TNF-blocking agent cannot be excluded (see Section 4.8).
Bit- tagħrif li hemm bħalissa, riskju li jiżviluppaw limfomi jew tumuri oħrajn f’ pazjenti kkurati b’ aġent li jinblokka TNF ma jistax jiġi eskluż (ara sezzjoni 4. 8).
Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Għandu jkun hemm kawtela meta tkun qed titqies terapija b’ inblokkatur ta ’ TNF għall- pazjenti li fil- passat kellhom tumur jew meta tkun qed tqies li tkompli l- kura f’ pazjenti li jiżviluppaw tumur.
Caution should also be exercised in patients with psoriasis and a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment.
Għandu jkun hemm kawtela wkoll f’ pazjenti bil- psorajiżi u passat mediku ta ’ terapija immunosoppressanti estensiva jew trattament PUVA fit- tul.
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including Remicade.
Wara t- tqegħid fis- suq kienu rrappurtati każijiet rari ta ’ limfoma epatosplenika taċ- ċelluli- T f’ pazjenti ikkurati b’ sustanzi inblukkaturi ta ’ TNF inkluż Remicade.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Din it- tip rari ta ’ limfoma taċ- ċelluli- T tinfirex b’ mod aggressiv ħafna u s- soltu tkun fatali.
All Remicade cases have occurred in patients with Crohn’ s disease or ulcerative colitis and the majority were reported in adolescent or young adult males.
Il- każijiet kollha b’ Remicade seħħew f’ pazjenti bil- marda ta ’ Crohn jew b’ infjammazzjoni ta ’ l- imsaren u l- parti l- kbira kienu rrappurtati f’ irġiel żagħżagħ adolexxenti jew adulti.
All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with or immediately prior to Remicade.
Dawn il- pazjenti kollha kienu qed jingħataw kura fl- istess ħin b’ azathioprine jew 6- mercaptopurine flimkien ma ’ jew wara Remicade.
The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
Ir- riskju li jista ’ jkun hemm bit- taħlita ta ’ AZA jew 6- MP u Remicade għandha titqies bir- reqqa.
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Remicade cannot be excluded (see sections 4.2 and 4.8).
Riskju li tiżviluppa limfoma epatosplenika taċ- ċelluli- T f’ pazjenti ttrattati b’ Remicade ma jistax jiġi eskluż (ara sezzjonijiet 4. 2 u 4. 8).
All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Il- pazjenti kollha b’ infjammazzjoni ta ’ l- imsaren li għandhom riskju akbar ta ’ displasja jew tumur tal - kolon (per eżempju, pazjenti f’ imfjammazzjoni ta ’ l- imsaren li tkun ilha jew kolanġite bi sklerożi ewlenija), jew li fil- passat kellhom displasja jew tumur tal- kolon għandhom ikunu eżaminati għal displasja f’ intervalli regolari qabel it- terapija u sakemm iddum il- marda tagħhom.
This evaluation should include colonoscopy and biopsies per local recommendations.
Din l- evalwazzjoni għandha tinkludi kolonoskopija u bijopsiji hekk kif ikun rakkomandat lokalment.
With current data it is not known if infliximab treatment influences the risk for developing dysplasia or colon cancer (see section 4.8).
Bit- tagħrif li hemm bħalissa mhux magħruf jekk it- trattament b’ infliximab jeffettwax ir- riskju sabiex jiżviluppaw displasja jew tumur tal- kolon (ara sezzjoni 4. 8).
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with Remicade is not established, the risk and benefits to the individual patients must be carefully reviewed and consideration should be given to discontinuation of therapy.
Peress li l- possibilità ta ’ riskju akbar li jiżviluppa tumur f’ pazjenti b’ displasja li tkun għada kif ġiet dijanjostikata li jkunu qed jiġu ttrattati b’ Remicade għada ma ġietx stabbilita, ir- riskju u l- benefiċċji għall- pazjenti individwali għandu jiġi rivedut bir- reqqa u ikun ikkonsidrat li titwaqqaf it- terapija.
Heart failure Remicade should be used with caution in patients with mild heart failure (NYHA class I/ II).
Insuffiċjenza tal- qalb Remicade għandu jintuża b’ attenzjoni f’ pazjenti b’ insuffiċjenza ħafifa tal- qalb (NYHA klassi I/ II).
Patients should be closely monitored and Remicade must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Il - pazjenti għandhom jinżammu taħt osservazzjoni mill- qrib u Remicade m’ għandux jitkompla f’ pazjenti li jiżviluppaw sintomi ġodda ta ’ insuffiċjenza tal- qalb jew jiħraxu s- sintomi li kellhom qabel (ara sezzjonijiet 4. 3 u 4. 8).
Paediatrics Due to insufficient data on safety and efficacy, Remicade is not recommended for use in children ≤ 17 years, except in Crohn’ s disease.
Pedjatriċi Minħabba li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja, l- użu ta ’ Remicade fi tfal ta ’ ≤17- il sena, mhux rakkomandat ħlief għall- marda ta ’ Crohn.
Remicade has not been studied in patients with Crohn’ s disease below the age of 6 years.
Remicade ma kienx studjat f’ pazjenti ta ’ taħt is- 6 snin bil- marda ta ’ Crohn.
Others The pharmacokinetics of infliximab in elderly patients has not been studied.
Oħrajn Il- farmakokinetiċi ta ’ infliximab f’ pazjenti anzjani ma kenitx studjata.
Studies have not been performed in patients with liver or renal disease (see section 5.2).
Ma sarux studji fuq pazjenti b’ mard tal- fwied jew tal- kliewi (ara sezzjoni 5. 2).
There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
M’ hemmx biżżejjed tagħrif ta ’ qabel l- użu kliniku sabiex wieħed jasal għal konklużjonijiet dwar l - effetti ta ’ infliximab fuq il- fertilità u l- funzjoni riproduttiva ġenerali (ara sezzjoni 5. 3).
There is limited safety experience of surgical procedures in Remicade treated patients.
9 Hemm esperjenza limitata dwar is- sigurtà ta ’ proċeduri kirurġiċi f’ pazjenti kkurati b’ Remicade.
The long half- life of infliximab should be taken into consideration if a surgical procedure is planned.
Il - half- life twila ta ’ Remicade għandha tiġi kkunsidrata jekk proċedura kirurġika qegħda tkun ippjanata.
A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Pazjent li għandu bżonn operazzjoni waqt li jkun fuq Remicade għandu jinżamm taħt osservazzjoni mill- qrib għal infezzjonijiet, u għandhom jittieħdu azzjonijiet xierqa.
There is limited safety experience of Remicade treatment in patients who have undergone arthroplasty.
Hemm esperjanza limitata dwar is- sigurtà ta ’ trattament b’ Remicade f’ pazjenti li kellhom ġog mibdul.
9 Failure to respond to treatment for Crohn’ s disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment.
Jekk ma jkunx hemm rispons għall- kura tal- marda ta ’ Crohn, dan jista ’ jindika li jkun hemm restrizzjoni fibrtika fissa li jista ’ jkollha bżonn titneħħa b’ kirurġija.
Available data suggest that infliximab does not worsen or cause strictures.
Hemm tagħrif li jindika li infliximab la jaggravax u lanqas jikkawża restrizzjonijiet.
In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
F’ pazjenti b’ sintomi ta ’ artrite rewmatika, artrite bi psorajiżi u l- marda ta ’ Crohn, hemm indikazzjonijiet li meta jingħataw methotrexate u immunomodulaturi oħra fl- istess waqt, dan inaqqas il- formazzjoni ta ’ antikorpi kontra infliximab u jżid il- konċentrazzjonijiet ta ’ infliximab fil- plażma.
However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Madankollu, hemm inċertezza dwar ir- riżultati minħabba limitazzjonijiet fil- metodi li ntużaw għall - analiżi ta ’ infliximab fis- serum u l- antikorpi kontra infliximab.
Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Ma jidhirx li kortikosterojdi jaffetwaw il- farmakokinetiċi ta ’ infliximab b’ livell li huwa relevanti b’ mod kliniku.
The combination of Remicade and anakinra is not recommended (see section 4.4 - "Concurrent administration of TNF-alpha inhibitor and anakinra”).
It- taħlita ta ’ Remicade u anakinra mhix rakkomandata (ara sezzjoni 4. 4 – “ L- għotja fl- istess ħin ta ’ inibitur TNF- alfa u anakiinra ”).
Nothing is known regarding possible interactions between infliximab and other active substances.
Xejn m’ hu magħruf dwar xi reazzjonijiet li jista ’ jkun hemm bejn infliximab u sustanzi attivi oħra.
It is recommended that live vaccines not be given concurrently with Remicade (see section 4.4 - “ Vaccinations”).
Huwa rakkomandat li vaċċini ħajjin ma jingħatawx flimkien ma ’ Remicade (ara sezzjoni 4. 4 – “ Tilqim ”).
Pregnancy Post-marketing reports from approximately 300 pregnancies exposed to infliximab, do not indicate unexpected effects on pregnancy outcome.
Tqala Rapporti li kien hemm wara t- tqegħid fis- suq minn madwar 300 tqala li kienu esposti għal infliximab, ma jindikawx li jista ’ jkun hemm effetti mhux mistennija fuq kif tispiċċa t- tqala.
Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn.
Minħabba l - impediment ta ’ TNFα meta infliximab jingħata waqt it- tqala jista ’ jkun hemm effetti fuq ir- rispons immuni tat- tarbija tat- twelid.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Fi studju dwar it- tossiċità fuq l- iżvilupp li sar fuq ġrieden permezz ta ’ antikorp analogu li b’ mod silettiv jimpedixxi l- attività funzjonali tat- TNFα tal- ġurdien, ma kienx hemm indikazzjoni ta ’ tossiċità għall- omm, tossiċità għall- embriju jew tertoġeniċità (ara sezzjoni 5. 3).
The available clinical experience is too limited to exclude a risk, and administration of infliximab is therefore not recommended during pregnancy.
L- esperjenza klinika li hemm s’ issa hija limitata wisq biex ikun eskluż riskju, u għalhekk l- għotja ta ’ infliximab mhijiex rakkomandata waqt it- tqala.
Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remicade treatment.
Nisa li jista ’ jkollhom it- tfal Nisa li jistgħu joħorġu tqal għandhom jagħmlu użu minn kontraċezzjoni xierqa biex jevitaw it- tqala u jkomplu jużawha mill- inqas għal 6 xhur wara l- aħħar trattament b’ Remicade.
Lactation It is not known whether infliximab is excreted in human milk or absorbed systemically after ingestion.
Treddigħ Mhux magħruf jekk infliximab joħroġx mal- ħalib tal- mara jew jekk ikunx assorbit b’ mod sistemiku wara li jinbela.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment.
Minħabba li immunoglobulini umani jitneħħew fil- ħalib tal- mara, in- nisa ma jistgħux ireddgħu mill- inqas għal 6 xhur wara trattament b’ Remicade.
In clinical studies with infliximab, adverse reactions were observed in approximately 60% of infliximab-treated patients and 40% of placebo-treated patients.
4. 8 Effetti mhux mixtieqa 10 Fi studji kliniċi b’ infliximab, effetti avversi tal- mediċina (ADRs) dehru f’ madwar 60% ta ’ pazjenti mogħtija infliximab u f’ 40% ta ’ pazjenti mogħtija plaċebo.
Infusion-related reactions were the most common adverse reactions reported.
Reazzjonijiet relatati ma ’ l- infużjoni kienu l- aktar reazzjonijiet avversi komuni rrappurtati.
Infusion-related reactions (dyspnoea, urticaria and headache) were the most common cause for discontinuation.
Reazzjonijiet relatati ma ’ l- infużjoni (dispneja, urtikarja u uġigħ ta ’ ras) kienu l- aktar kawżi komuni għat- twaqqif.
10 Table 1 lists the adverse reactions based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Tabella 1 telenka r- reazzjonijiet avversi li ġejjin minn studji kliniċi kif ukoll reazzjonijiet avversi, li xi wħud wasslu għall- mewt, irrappurtati minn esperjenza ta ’ wara t- tqegħid fis- suq.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Fis- sistema ta ’ l - organi, il- klassijiet tas- sistema, ir- reazzjonijiet avversi huma elenkati taħt it- titli tal- frekwenza bil - kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1000 sa < 1/ 100); rari( ≥1/ 10, 000 sa < 1/ 1, 000).
Because post-marketing events are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
L - effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
Table 1 Undesirable Effects in Clinical Studies and from Post-Marketing Experience
Tabella 1 Effetti mhux mixtieqa fi Studji Kliniċi u mill- Esperjenza ta ’ Wara t- Tqegħid fis- Suq
Infections and infestations Common:
Infezzjonijiet u infestazzjonijiet Komuni:
Viral infection (e. g. influenza, herpes virus infection) Uncommon:
Infezzjoni virali (eż. influwenza, infezzjonijiet bil- vajrus ta’ l- erpes) Mhux komuni:
Sepsis, tuberculosis, abscess, bacterial infection, fungal infection, cellulitis, candidiasis Unknown:
Sepsi, tuberkulożi, sepsi, qrada, infezzjoni ta ’ batteri, infezzjoni tal - fungi, ċellulite, kandidijażi Mhux magħruf:
Opportunistic infections (such as atypical mycobacterial infection, pneumocystosis, histoplasmosis, coccidioidomycosis, cryptococcosis, aspergillosis and listeriosis), hepatitis B reactivation, salmonellosis Neoplasms benign, malignant and unspecified (including cysts and polyps) Unknown:
Infezzjonijiet opportunistiċi (bħal infezzjoni b’ mikobatteri mhux tipika, pnewmoċistożi, istoplażmożi, kokkidijodomikożi, kriptokokkożi, asperġillożi u listerijożi), ri- attivazzjoni ta ’ epatite B, salmonellożi Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux magħruf:
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn’ s disease and ulcerative colitis), lymphoma (including non-Hodgkin’ s lymphoma and Hodgkin’ s disease) Blood and lymphatic system disorders Uncommon:
Limfoma epatosplenika taċ- ċelluli- T (l- aktar f’ adolexxenti u adulti żagħżagħ bil- marda ta ’ Crohn u infjammazzjoni ta ’ l- imsaren), limfoma (inkluża limfoma mhux ta ’ Hodgkin u marda ta ’ Hodgkin) Disturbi tad- demm u tas- sistema limfatika Mhux komuni:
Neutropenia, leukopenia, thrombocytopenia, anaemia, lymphopenia, lymphadenopathy, lymphocytosis Unknown:
Newtropenja, lewkopenja, tromboċitopenja, anemija, limfopenja, limfadenopatija, limfoċitożi Mhux magħruf:
Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura Immune system disorders Common:
Agranuloċitożi, purpura tromboċitopenika trombotika, panċitopenja, anemija emolitika, purpura tromboċitopenika idjopatika Disturbi fis- sistema immuni Komuni:
Serum sickness-like reaction Uncommon:
Reazzjonijiet bħal mard tas- serum Mhux komuni:
Anaphylactic reaction, lupus-like syndrome, allergic respiratory symptom Unknown:
Reazzjonijiet anafilattiċi, sindrome bħal tal- lupus, sintomu respiratorju allerġiku Mhux magħruf:
Anaphylactic shock, serum sickness, vasculitis Psychiatric disorders Uncommon:
Xokk anafilattiku, mard tas- serum, vaskulite Disturbi psikjatriċi Mhux komuni:
Depression, amnesia, agitation, confusion, insomnia, somnolence, nervousness, apathy Nervous system disorders Common:
Dipressjoni, amneżija, aġitazzjoni, konfużjoni, nuqqas ta ’ irqad, ngħas, nervożismu, apatija Disturbi fis- sistema nervuża Komuni:
Headache, vertigo, dizziness Uncommon:
Uġigħ ta ’ ras, vertigo/ sturdament Mhux komuni:
Central nervous system demyelinating disorders (multiple sclerosis-like disease) Rare:
Disturbi b’ mard li jneħħi l- majelin tas- sistema nervuża ċentrali (mard li jixbah l- isklerożi multipla) Rari:
Meningitis Unknown:
Meninġite
11 Uncommon:
11 Mhux magħruf:
Cardiac failure aggravated, arrhythmia, syncope, bradycardia, cyanosis, palpitation Rare:
Insuffiċjenza tal- qalb taggrava, arritmja, sinkope, qalb tħabbat bil - mod, ċijanosi, palpitazzjoni Rari:
Tachycardia Unknown:
Qalb tħabbat bil- għaġġla Mhux magħruf:
Cardiac failure, pericardial effusion Vascular disorders Common:
Insuffiċjenza tal- qalb, effużjoni perikadijaka Disturbi vaskulari Komuni:
Flushing Uncommon:
Pazjent isir ruxxan Mhux komuni:
Hypotension, peripheral ischaemia, hypertension, thrombophlebitis, haematoma, ecchymosis, petechia, vasospasm, hot flush Rare:
Pressjoni baxxa, iskemija periferali, pressjoni għolja, tromboflebite, ħematoma, ekkimożi, petekja, vażospasmu, fwawar ta ’ sħana Rari:
Circulatory failure Respiratory, thoracic and mediastinal disorders Common:
Insuffiċjenza ċirkolatorja Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Lower respiratory tract infection (e. g. bronchitis, pneumonia), upper respiratory tract infection, sinusitis, dyspnoea Uncommon:
Infezzjoni tan- naħa ta ’ isfel tat- tratt respiratorju (eż. bronkite, pulmonite), infezzjoni tan- naħa ta ’ fuq tat- tratt respiratorju, sinużite, dispneja Mhux komuni:
Pulmonary oedema, bronchospasm, pleurisy, epistaxis Rare:
Edema fil- pulmun, bronkospażmu, plewriżi, epistassi Rari:
Pleural effusion Unknown:
Effużjoni fil- plewra Mhux magħruf:
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis) Gastrointestinal disorders Common:
Mard fl- interstizzju tal- pulmun (inkluż mard li javvanza malajr, fibrożi fi; - pulmun u pnewmonite) Disturbi gastro- intestinali Komuni:
Abdominal pain, diarrhoea, nausea, dyspepsia Uncommon:
Uġigħ addominali, dijarea, dardir, dispepsja Mhux komuni:
Diverticulitis, gastroesophageal reflux, constipation, cheilitis Rare:
Divertikulite, rifluss mill- istonku, stitikezza, kejlite Rari:
Intestinal perforation, gastrointestinal haemorrhage, intestinal stenosis Unknown:
Titqib fil- musrana, emorraġija fil- musrana jew fl- istonku, djuq fil - musrana Mhux magħruf:
Pancreatitis Hepatobiliary disorders Common:
Pankrejatite Disturbi fil- fwied u fil- marrara Komuni:
Transaminases increased Uncommon:
Żieda fit- transaminases Mhux Komuni:
Cholecystitis, hepatic function abnormal Rare:
Koleċistite, funzjoni tal- fwied anormali Rari:
Hepatitis Unknown:
Epatite Mhux magħruf:
Liver failure, autoimmune hepatitis, hepatocellular damage, jaundice Skin and subcutaneous tissue disorders Common:
Insuffiċjenza tal- fwied, epatite awtoimmuni, ħsara fiċ- ċelluli tal - fwied, suffejra Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni:
Urticaria, rash, pruritus, hyperhidrosis, dry skin Uncommon:
Urtikarja, raxx, ħakk, iperidrożi, ġilda xotta Mhux komuni:
Bullous eruption, furunculosis, fungal dermatitis, onychomycosis, eczema, seborrhoea, rosacea, skin papilloma, hyperkeratosis, alopecia, abnormal skin pigmentation Unknown:
Joħorġu l- imsiemer, gundalli, dermatite b’ infezzjoni tal- moffa, onikomikożi, seborreja, rosaċja, papilloma tal- ġilda, iperkeratożi, alopeċja, kulur tal- ġilda anormali Mhux magħruf:
Toxic epidermal necrolysis, Stevens-Johnson-Syndrome, psoriasis, including new onset and pustular (primarily palm & soles), erythema multiforme Musculoskeletal and connective tissue disorders Uncommon:
Nekroliżi tossika ta ’ l- epidermide, Sindrome Stevens- Johnson, psorajiżi, inkluża dik li tibda għall- ewwel darba u pustulari (l- aktar fil- pala ta ’ l- id u s- saqajn), erythema multiforme Disturbi muskolu- skeletrali u tal - connective tissue Mhux komuni:
Arthralgia, myalgia, back pain Renal and urinary disorders Uncommon:
Artralġja, uġigħ fil- muskoli, uġigħ fid- dahar Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni:
Pyelonephritis, urinary tract infection Reproductive system and breast disorders Uncommon:
12 Disturbi fis- sistema riproduttiva u fis- sider Mhux komuni:
Vaginitis General disorders and administration site conditions Common:
Vaġinite Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni:
Infusion-related reaction, chest pain, fatigue, fever Uncommon:
Reazzjoni mnejn tingħata l- injezzjoni, uġigħ fis- sider, għeja, deni Mhux komuni:
Impaired healing, injection site reaction, chills, oedema, pain Rare:
Fejqan imxekkel, reazzjoni relatata ma ’ l- injezzjoni, dehxiet, edema, uġigħ Rari:
Granulomatous lesion Investigations Uncommon:
Leżjoni granulomatoża Investigazzjonijiet Mhux komuni:
Autoantibody positive, complement factor abnormal
Awto- antikorpi pożittivi, anormailtà fill- fattur tal- komplement
12 Infusion-related reactions:
Reazzjonijiet relatati ma ’ l- infużjoni:
An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 to 2 hours after an infusion.
Reazzjoni relatata ma ’ l- infużjoni kienet definita fi studji kliniċi bħala kull reazzjoni mhux mixtieqa li sseħħ waqt infużjoni jew minn siegħa sa sagħtejn wara infużjoni.
In clinical studies, approximately 20% of infliximab-treated patients compared with approximately 10% of placebo- treated patients experienced an infusion-related effect.
Fi studji kliniċi, 20% tal- pazjenti li ngħataw infliximab kellhom xi effett relatat ma ’ l - infużjoni mqabbel ma ’ madwar 10% ta ’ pazjenti li ngħataw plaċebo.
Approximately 3% of patients discontinued treatment due to infusions reactions and all patients recovered with or without medical therapy.
Madwar 3% tal- pazjenti ma komplewx it- trattament minħabba reazzjonijiet ta ’ l- infużjoni u l- pazjenti kollha rkupraw b’ terapija medika jew waħidhom.
In a clinical study of patients with rheumatoid arthritis (ASPIRE), sixty six percent of the patients (686 out of 1040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1040) received at least one shortened infusion of 60 minutes or less.
Fi studju kliniku fuq pazjenti b’ artrite rewmatika (ASPIRE), sitta u sittin fil - mija tal- pazjenti (686 minn 1040) irċevew mill- anqas infużjoni waħda mqassra ta ’ 90 minuta jew anqas u 44% tal- pazjenti (454 minn 1040) irċevew mill- anqas infużjoni waħda imqassra ta ’ 60 minuta jew anqas.
Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Mill- pazjenti ttrattati b’ imfliximab li rċevew mill- anqas infużjoni waħda mqassra, reazzjonijiet relatati ma ’ l- infużjoni seħħew fi 15% tal- pazjenti u reazzjonijiet serji seħħew f’ 0. 4% tal - pazjenti.
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/ pharyngeal oedema and severe bronchospasm, and seizure have been associated with Remicade administration.
F’ esperjenza wara li tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet jixbħu anafilattiċi, fosthom edema tal- larinġi/ farinġi u spażmu qawwi tal- bronki, kif ukoll aċċessjonijiet kienu assoċjati ma ’ l- għotja ta ’ Remicade.
Delayed hypersensitivity:
Sensittività eċċessiva ttardjata:
In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year.
Fi studji kliniċi reazzjonijiet ta ’ sensittività eċċessiva ittardjata ma kienux komuni u seħħew wara intervalli mingħajr Remicade ta ’ anqas minn sena.
In the psoriasis studies, delayed hypersensitivity reactions occurred early in the treatment course.
Fl- istudji fuq il - psorajiżi, reazzjonijiet ta ’ sensittività eċċessiva seħħew kmieni meta beda t- trattament.
Signs and symptoms included myalgia and/ or arthralgia with fever and/ or rash, with some patients experiencing pruritus, facial, hand or lip edema, dysphagia, urticaria, sore throat and headache.
Sinjali u sintomi kienu jikludu wġigħ fil- muskoli u/ jew artralġja b’ deni u/ jew raxx b’ xi pazjenti kellhom ukoll ħakk, edema fil- wiċċ, idejn jew xofftejn, problemi biex jibilgħu, urtikarja, uġigħ fil- grieżem u/ jew uġigħ ta ’ ras.
There are insufficient data on the incidence of delayed hypersensitivity reactions after Remicade-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval.
M’ hemmx tagħrif biżżejjed dwar l- inċidenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva ittardjata wara intervalli mingħajr Remicade ta ’ aktar minn sena iżda t- tagħrif limitat li hemm minn studji kliniċi jindika riskju akbar għal sensittività eċċessiva aktar ma jikber l- intervall mingħajr Remicade.
In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Fi studju kliniku ta ’ sena b ’ infużjonijiet ripetuti f’ pazjenti bil- marda ta ’ Crohn (studju ACCENT I), l - inċidenza ta ’ reazzjonijiet bħal ta ’ mard tas- serum kienet ta ’ 2. 4%.
Immunogenicity:
Immunoġeniċità:
Patients who developed antibodies to infliximab were more likely (approximately 2- 3 fold) to develop infusion-related reactions.
Pazjenti li saru pożittivi għal antikorpi għal infliximab kellhom probabbiltà akbar (xi 2- 3 darbiet aktar) li jiżviluppaw reazzjonijiet ta ’ l- infużjoni minn dawk li kienu negattivi.
Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Meta fl - istess waqt intużaw aġenti immunosoppressivi, deher illi l- frekwenza ta ’ reazzjonijiet relatati ma ’ l - infużjoni naqset.
In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/ kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Fi studji kliniċi fejn intużat doża waħda jew ħafna dożi ta ’ infliximab minn 1 sa 20 mg/ kg, instabu antikorpi għal infliximab f’ 14% tal- pazjenti fuq xi terapija immunosoppressiva, u f’ 24% tal- pazjent mingħajr terapija immunosoppressiva.
In psoriatic arthritis patients who received 5 mg/ kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
F’ pazjenti b ’ sintomi ta ’ artrite rewmatika li ngħataw il- kors ta ’ trattament b’ dożi ripetuti kif rakkomandat, flimkien ma ’ methotrexate, 8% tal - pazjenti żviluppaw antikorpi għal infliximab. F’ pazjenti bi psorajiżi li rċevew 5 mg/ kg b’ methotrexate jew mingħajru, fi 15% tal- pazjenti iffurmaw antikorpi (l- antikorpi iffurmaw f’ 4% tal- pazjenti li rċevew methotrexate u 26% tal- pazjenti li ma kienux qed jirċievu methotrexate mal- linja bażi).