qanastek/EMEA-V3 huggingface dataset:
For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Għall- indikazzjonijiet kollha t’ hawn fuq, l- informazzjoni li għandna tindika, li s- soltu, ir- rispons kliniku jintlaħaq fi żmien 12 - il ġimgħa ta ’ kura.
Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Wieħed għandu jirrikonsidra b’ attenzjoni jekk għandhiex titkompla l- kura f’ każ ta’ pazjent li ma jkunx irrisponda f’ dan il- perijodu ta ’ żmien.
The recommended Humira induction dose regimen for adult patients with severe Crohn’ s disease is 80 mg at Week 0 followed by 40 mg at Week 2.
Id- dożaġġ irrakkomandat biex tinbeda l- kura b’ Humira fuq pazjenti adulti li jbatu mill- marda Crohn (Crohn’ s disease) severa huwa ta ’ 80 mg f’ Ġimgħa 0 segwiti b’ 40 mg f’ Ġimgħa 2.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at Week 2, can be used with the awareness that the risk for adverse events is higher during induction.
F’ każ li jkun hemm bżonn ta ’ rispons għat- terapjia aktar mgħaġġel, dożaġġ ta’ 160 mg f’ Ġimgħa 0 (id- doża tista ’ tingħata permezz ta ’ erba ’ injezzjonijiet f’ ġurnata waħda jew inkella bħala żewġ injezzjonijiet kull ġurnata għal jumejn konsekuttivi) u 80 mg f’ Ġimgħa 2 jista ’ jingħata però, f’ dan il- każ, wieħed għandu jżomm f’ moħħu l- fatt li r- riskju ta ’ effetti avversi waqt il- bidu tat- terapija ikun ogħla.
After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Wara l- kura tal- bidu, id- doża rrakkomandata hija ta ’ 40 mg ġimgħa iva u ġimgħa le permezz ta ’ injezzjoni taħt il- ġilda.
Alternatively, if a patient has stopped Humira and signs and symptoms of disease recur, Humira may be re-administered.
Jew inkella, jekk pazjent ikun waqaf jieħu Humira u s- sinjali u s- sintomi tal - marda jerġgħu joħorġu, Humira jista ’ jerġa ’ jingħata.
There is little experience from re-administration after more than 8 weeks since the previous dose.
L- esperjenza dwar it- teħid ta ’ Humira għal darba oħra wara li jkunu għaddew aktar minn 8 ġimgħat mill- aħħar doża, hija żgħira.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Waqt il- kura ta ’ manteniment, il- corticosteroids jistgħu jiġu mnaqqsa ftit ftit sakemm ma jibqgħux jingħataw, u dan skond il- linji gwida tal- prattika klinika.
Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Humira every week.
Xi pazjenti li jesperjenzaw tnaqqis fir- rispons tagħhom jistgħu jibbenifikaw minn żieda fl- intensità tad- doża għal 40 mg Humira kull ġimgħa.
Some patients who have not responded by Week 4 may benefit from continued maintenance therapy through Week 12.
Xi pazjenti li ma jkollhomx rispons sa Ġimgħa 4 jistgħu jibbenefikaw minn terapija ta ’ manteniment li titkompla sa Ġimgħa 12.
Continued therapy should be carefully reconsidered in a patient not responding within this time period.
F’ każ ta ’ pazjent li ma jkollu l- ebda rispons f’ dan il- perijodu ta ’ żmien, wieħed għandu jerġa ’ jaħsibha sewwa dwar jekk għandhiex titkompla t- terapija.
The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Id- doża ta ’ Humira rrakkomandata għal pazjenti adulti hija doża inizjali ta ’ 80 mg mogħtija taħt il - ġilda, u wara li tgħaddi ġimgħa mid- doża inizjali, għandha tibda tingħata taħt il- ġilda doża ta ’ 40 mg ġimgħa iva u ġimgħa le.
Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
It- tkomplija tat- terapija għal aktar minn 16 - il ġimgħa għandha tiġi kkunsidrata b’ attenzjoni f’ każ ta ’ pazjent li ma kellux rispons f’ dan il- perijodu.
Elderly patients
Pazjenti anzjani
No dose adjustment is required.
M’ hemmx bżonn ta ’ aġġustament tad- doża.
Children and adolescents (aged 13 to 17 years)
Tfal u adoloxxenti (li għandhom bejn 13 u 17 il- sena)
Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 years and above is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Artrite idjopatika poliartikulari taż- żagħżagħ Id- doża ta ’ Humira rrakkomandata għal pazjenti b ’ artrite idjopatika poliartikulari taż- żagħżagħ li għandhom 13 il- sena u fuqhom hi 40mg adalimumab, mogħtija b’ injezzjoni taħt il- ġilda, ġimgħa iva u ġimgħa le, bħala doża waħda.
Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
4 Informazzjoni li għandna turi li r- rispons kliniku jintleħaq fi 12- il ġimgħa ta ’ kura.
Continued therapy should be carefully reconsidered in a patient not responding within this time period.
It- tkomplija tal - kura għandha tiġi kkunsidrata mill- ġdid f’ pazjenti li ma wrewx titjib f’ dan iż- żmien.
4 Impaired renal and/ or hepatic function
Indeboliment tal- funzjoni renali u/ jew tal- fwied
Humira has not been studied in these patient populations.
Humira ma ġiex studjat fuq dawn il- populazzjonijiet ta ’ pazjenti.
No dose recommendations can be made.
Ma jistgħu jsiru l- ebda rakkomandazzjonijiet rigward doża.
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Tuberkulosi attiva jew infezzjonijiet oħra severi bħal sepsis, u infezzjonijiet opportunistiċi (ara sezzjoni 4. 4).
Moderate to severe heart failure (NYHA class III/ IV) (see section 4.4).
Insuffiċjenza tal- qalb minn moderata sa severa (NYHA klassi III/ IV) (ara sezzjoni 4. 4).
Patients taking TNF-blockers are more susceptible to serious infections.
Pazjenti li qed jieħdu mediċini li jimblukkaw t- TNF huma suxxettibli aktar għal infezzjonijiet serji.
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira.
Għalhekk il- pazjenti għandhom jiġu monitorjati mill- qrib għal infezzjonijiet, inkluż t- tuberkulosi, kemm qabel, waqt, kif ukoll wara l- kura b’ Humira.
Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period.
Minħabba li l- eliminazzjoni ta ’ adalimumab tista ’ tieħu sa ħames xhur, l- osservazzjoni għandha titkompla ukoll matul dan il- perijodu.
Treatment with Humira should not be initiated in patients with active infections including chronic or localized infections until infections are controlled.
F’ pazjenti li jkollhom infezzjonijiet attivi, li jinkludu infezzjonijiet kroniċi jew lokalizzati, m’ għandhiex tinbeda kura b’ Humira sakemm jiġu kontrollati l- infezzjonijiet.
In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Opportunistic infections).
F’ pazjenti li kienu diġa esposti għat- tuberkulożi u pazjenti li vvjaġġaw f’ żoni ta ’ riskju għoli ta ’ tuberkulożi jew mikożji endemiċi bħal histoplasmosis, coccidioidomycosis, jew blastomycosis, ir- riskji u l- benefiċċji tat - terapija b’ Humira għandhom jiġu kkunsidrati qabel ma tinbeda l- kura (ara infezzjonijiet opportunistiċi).
Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
Pazjenti li jiżviluppaw infezzjoniji ġdida waqt li jkunu qegħdin taħt il- kura b’ Humira, għandhom jiġu monitorjati mill- qrib u għandhom jagħaddu minn evalwazzjoni dianjostika sħieħa.
Administration of Humira 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.
F’ każ li pazjent jiżviluppa infezzjoni serja ġdida jew sepsis, it- teħid ta ’ Humira għandu jitwaqqaf u għandha tingħata kura xierqa b ’ aġenti antimikrobiotiċi jew antifungali sakemm l- infezzjoniji tiġi kontrollata.
Physicians should exercise caution when considering the use of Humira in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
It- tobba għandhom joqogħdu attenti meta jkunu qegħdin jikkunsidraw l- użu ta ’ Humira fuq pazjenti li għandhom storja ta ’ infezzjoni li tfeġġ minn żmien għal żmien jew ta ’ kundizzjonijiet eżistenti li jistgħu jippredisponu l- pazjenti għal infezzjonijiet, inkluż l- użu konkomitanti ta ’ medikazzjonijiet immunosoppressanti.
Serious infections:
Infezzjonijiet serji:
Serious infections,, including sepsis, due to bacterial, mycobacterial, invasive fungal viral, or other opportunistic infections such as listeriosis, and pneumocystis have been reported in patients receiving Humira.
Infezzjonijiet serji, li jinkludu sepsis kkawżati minn battreji, myco- batterji u fungus virali invażiv u infezzjonijiet opportunistiċi oħra bħal listeriżi u pneumocystis, ġew rapportati f’ pazjenti li kienu qed jirċievu Humira.
Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Infezzjonijiet oħra serji osservati fi provi kliniċi jinkludu pnewmonja, infjammazjoni fil- kliewi (pyelonephritis), artrite settika u settiċemija.
Hospitalisation or fatal outcomes associated with infections have been reported.
Kienu rrapurtati wkoll każijiet fatali jew fejn il- pazjenti kellhom jiddaħħlu l- isptar.
Tuberculosis:
Tuberkulosi:
There have been reports of tuberculosis in patients receiving Humira.
Kien hemm rapporti ta ’ tuberkulosi f’ pazenti li jierċievu Humira.
It should be noted that in the majority of those reports, tuberculosis was extra-pulmonary, i. e. disseminated.
Wieħed għandu jinnota li fil - maġġoranza ta ’ dawn ir- rapporti, it- tuberkulosi instabet barra mill- pulmun, jiġifieri l- infezzjoni kienet mifruxa.
Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
5 Qabel tinbeda l- kura b’ Humira, il- pazjenti kollha għandhom jiġu evalwati għall- infezzjoni tat - tuberkulosi kemm attiva kif ukoll mhux attiva (rieqda).
This evaluation should include a detailed medical history of patients with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/ or current immunosuppressive therapy.
Din l- evalwazzjoni għandha tinkludi l- istorja medika tal- pazjenti fid- dettall, bl- istorja personali tat- tuberkulosi jew esponimenti għal pazjenti b’ tuberkulosi attiva li seta ’ kien hemm fil- passat, u terapija immunosuppressanti li ngħatat fil- passat u/ jew li tkun qiegħda tingħata.
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may
Testijiet xierqa għall- iċċekjar, jiġifieri test tal- ġilda għat- tuberkolina u X- ray tas- sider, għandhom isiru fuq il- pazjenti kollha (rakkomandazzjonijiet lokali jistgħu japplikaw).
It is recommended that the conduct of these tests should be recorded in the patient alert card.
Huwa rrakkomandat li l- fatt li dawn it- testijiet saru għandu jitniżżel fuq il- kartuna ta ’ twissija 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 jagħti l- mediċina huwa mfakkar fir- riskju ta ’ testijiet negattivi tal- ġilda għat- tuberkolina foloz, speċjalment f’ pazjenti li huma morda serjament jew li għandhom immunità kompromessa.
If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3).
Jekk ikun hemm dijanjosi ta ’ tuberkulosi attiva, it- terapija b’ Humira m’ għandhiex tinbeda (ara sezzjoni 4. 3).
If latent tuberculosis issuspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Jekk ikun hemm suspett ta ’ tuberkulosi rieqda, għandu jiġi kkonsultat tabib li jkun espert fil- kura tat - tuberkulosi.
In all situations described below, the benefit/ risk balance of therapy should be very carefully considered.
Fis- sitwazzjonijiet kollha deskritti hawn taħt, il- bilanċ ta ’ benefiċċju/ riskju tat- terapija għandu jiġi kkunsidrat b’ attenzjoni kbira.
If inactive (‘ latent’) tuberculosis is diagnosed, appropriate treatment for latent tuberculosis must be started with anti-tuberculosis prophylaxis therapy before the initiation of Humira, and in accordance with local recommendations.
Jekk ikun hemm dijanjosi ta ’ tuberkulosi mhux attiva (‘ rieqda ’), għandha tinbeda kura għat - tuberkulosi rieqda permezz ta ’ kura għal kontra t- tuberkulosi qabel ma tinbeda l- kura b’ Humira, u skond 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 also be considered before the initiation of Humira.
Fil- każ ta ’ pazjenti li għandhom ħafna, jew ammont sinifikanti ta ’ fatturi ta ’ riskju għat- tuberkulosi u li t- test tat- tuberkulosi rieqda mmarkalhom fin- negattiv, għandha tiġi kkunsidrata ukoll terapija għal kontra t- tuberkulosi qabel ma tinbeda l- kura b’ Humira.
Use of anti-tuberculosis therapy should also be considered before the initiation of Humira 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 għal kontra t- tuberkulosi għandu jiġi kkunsidrat ukoll qabel ma tinbeda l- kura b’ Humira f’ każ ta ’ pazjenti li għandhom storja ta ’ tuberkulosi rieqda jew attiva, u li fil- każ tagħhom ma jistgħax jiġi kkonfermat jekk huma ħadux kura adegwata għaliha jew le.
Some patients who have previously received treatment for latent or active tuberculosis have developed active tuberculosis while being treated with Humira.
Uħud mill- pazjenti li digà irċevew kura għat- tuberkulosi rieqda jew attiva żviluppaw tuberkulosi attiva fl- istess waqt li kienu qegħdin jiġu kkurati b’ Humira.
Patients should be instructed to seek medical advice if signs/ symptoms (e. g., persistent cough, wasting/ weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Humira.
Il- pazjenti għandhom ikunu avżati biex jitolbu parir mediku jekk sinjali/ sintomi (eż, sogħla persisitenti, telf ta ’ muskoli/ tnaqqis fil- piż, deni ta ’ grad baxx) li jindikaw infezzjoni tat- tuberkulosi ifeġġu waqt jew wara t- terapija b’ Humira.
Other opportunistic infections:
Infezzjonijiet opportunistiċi oħra:
Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
Infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, ġew osservati f’ pazjenti li kienu qed jirċievu Humira.
These infections have not consistently been recognised in patients taking TNF-blockers and this resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Dawn l- infezzjonijiet ma ġewx innutati mill- ewwel f’ pazjenti li qed jieħdu mediċini li jimblukkaw t- TNF u dan irriżulta f’ dewmien biex jinbeda trattament addattat, u xi drabi wassal għal- riżultat fatali.
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnea, and/ or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasivie fungal infection should be suspected and administration of Humira should be promptly discontinued and appropriate antifungal therapy should be initiated.
F’ pazjenti li jiżviluppaw sintomi ta ’ deni, telqa tal- ġisem mingħajr l- ebda sinjali ta ’ mard, telf tal- piż, ixoqq l- għaraq għalihom, sogħola, li- jkollhom diffikulta biex jieħdu n- nifs, u/ jew ikollhom infiltrate fil pulmun jew sintomi serji oħra ta ’ mard sistemiku flimkien ma jew mingħajr xokk, għandha tigi kkunsidrata infezzjoni fungali invażiva u l- amministrazzjoni ta’ Humira għandha tiġi mwaqqfa immedjatament u tinghata kura antifungali.
Hepatitis B Reactivation
Riattivazzjoni ta ’ Epatite B
Reactivation of hepatitis B has occurred in patients who are chronic carriers of this virus when receiving a TNF-antagonist including Humira.
Seħħet riattivazzjoni ta ’ epatite B f’ pazjenti li jġorru dan il- virus b’ mod kroniku u li jirċievu xi antagonist ta ’ TNF, inkluż Humira.
Some cases have had a fatal outcome.
Xi każi kellhom riżultat fatali.
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Humira therapy.
Qabel ma tinbeda t- terapija b’ Humira, pazjenti li qegħdin f’ riskju li jaqbadhom infezzjoni HBV għandhom jiġu eżaminati għal evidenza ta ’ infezzjoni HBV li seta ’ kellhom qabel.
Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Persuni li jġorru l- HBV u li jkollhom bżonn il - kura b’ Humira għandhom jiġu monitorjati għal sinjali u sintomi ta ’ infezzjoni HBV attiva matul it - terapija u għal ħafna xhur wara li titwaqqaf it- terapija.
Adequate data from the treatment of patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
M’ hawnx informazzjoni adegwata fuq il- kura ta ’ pazjenti li jġorru l- HBV permezz ta ’ terapija anti- virali flimkien ma ’ terapija b’ antagonist ta ’ TNF
In patients who develop HBV reactivation, Humira should be stopped and effective anti- viral therapy with appropriate supportive treatment should be initiated.
Humira għandu jitwaqqaf u għandha tinbeda terapija anti - virali effettiva akkumpanjata b’ kura adegwata supportiva f’ każ ta ’ pazjenti li jiżviluppaw riattivazzjoni ta ’ l- HBV.
Neurological events
Effetti Newroloġiċi
TNF-antagonists including Humira have been associated in rare instances with new onset or exacerbation of clinical symptoms and/ or radiographic evidence of demyelinating disease including multiple sclerosis.
Antagonisti- TNF, inluż Humira, ġew assoċjati f’ okkażjonijiet rari, ma ’ sintomi kliniċi ġodda jew taħrix ta ’ sintomi kliniċi u/ jew evidenza radjografika ta ’ mard li jaffetwaw il- myelin tan- nervituri u jinkludu sklerożi multipla.
Prescribers should exercise caution in considering the use of Humira in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
Min jagħti l- mediċina għandu joqgħod attent meta jikkunsidra l- użu ta ’ Humira fuq pazjenti li diġà għandhom jew li qabduhom riċentement, disturbi li jaffetwaw il- myelin fis- sistema ċentrali nervuża.
6 Allergic reactions
Reazzjonijiet allerġiċi
Serious allergic adverse reactions have not been reported with subcutaneous administration of Humira during clinical trials.
Matul provi kliniċi, ma ġewx irrappurtati reazzjonijiet avversi serji bl- użu ta ’ Humira taħt il- ġilda.
Non-serious allergic reactions associated with Humira were uncommon during clinical trials.
Reazzjonijiet allerġiċi li m’ humiex serji assoċjati ma ’ Humira, ma kinux komuni matul il- provi kliniċi.
In postmarketing, serious allergic reactions including anaphylaxis have been reported very rarely following Humira administration.
Wara li l- prodott tqiegħed fis- suq, reazzjonijiet allerġiċi serji, li jinkludu l- anafilassi, ġew irrappurtati f’ każi rari ħafna wara li ttieħed Humira.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Humira should be discontinued immediately and appropriate therapy initiated.
Jekk ikun hemm reazzjoni anafilattika jew reazzjoni allerġika serja oħra, it- teħid ta ’ Humira għandu jitwaqqaf immedjatament, u għandha tinbeda terapija adattata.
The needle cover of the syringe contains natural rubber (latex).
L- għatu tal- labra tas- siringa fih lastiku naturali (latex).
This may cause severe allergic reactions in patients sensitive to latex.
Dan jista ’ jikkaġuna reazzjonijiet allerġiċi severi f’ pazjenti li huma sensittivi għal- latex.
Immunosuppression
Immunosoppressjoni
In a study of 64 patients with rheumatoid arthritis that were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, - NK-cells, monocyte/ macrophages, and neutrophils.
Fi studju ta ’ 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b’ Humira, ma kien hemm l - ebda evidenza ta ’ tnaqqis ta ’ sensitività eċċessiva imdewma, tnaqqis tal- livelli ta ’ immunoglobuli, jew tibdil fin- numri ta ’ ċelloli effettivi T -, B -, NK -, monoċistiċi / makrofaġi, u newtrofili.
Malignancies and lymphoproliferative disorders
Tumuri malinni u disturbi li jaffetwaw it- tkattir tal- limfoċiti
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Fil- porzjonijiet kontrollati tal- provi kliniċi ta ’ antagonisti ta ’ TNF, ġew osservati aktar każi ta ’ tumuri malinni, inkluż limfoma, f’ pazjenti li jirċievu xi anagonist ta ’ TNF, meta ipparagunati ma ’ pazjenti kontrollati.
However, the occurrence was rare.
Madanakollu, l- okkorrenza kienet rari.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Barra minn hekk, hemm sfond ta ’ riskju akbar ta ’ limfoma f’ pazjenti li jbatu minn artrite rewmatika b’ mard infjammatorju li jkun ilu u li hu attiv ħafna, li jikkomplika l- istima tar- riskju.
With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Mill- informazzjoni li għandna s’ issa, ma tistax tiġi eskluża l - possibilità ta ’ żvilupp ta ’ tumuri limfoma jew tumuri malinni oħra f’ pazjenti kkurati b’ xi antagonist ta ’ TNF.
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Wara li l- prodott tqiegħed fis- suq, kienu identifikati każijiet rari ta ’ hepatosplenic T- cell lymphoma f’ pazjenti trattati b ’ adalimumab.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Din it- tip ta ’ T- cell lymphoma rari hi aggressiva ħafna u ġeneralment tkun fatali.
Some of these hepatosplenic T-cell lymphomas with Humira have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for Crohn’ s disease.
Xi wħud min dawn il- hepatosplenic T- cell lymphomas b’ Humira ġew osservati f’ pazjenti żgħar adulti meta kienu qed jigu wkoll trattati b ’ azathioprine jew 6 - mercaptopurine li jintuzaw għall- kura tal- marda Crohn (Crohn’ s disease).
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded (see section 4.8).
Ma jistax jiġi eskluż ir - riskju li tiżviluppa hepatosplenic T- cell lymphoma f’ pazjenti ttratati b ’ Humira (ara sezzjoni 4. 8).
No studies have been conducted that include patients with a history of malignancy or in whom treatment with Humira is continued following development of malignancy.
Ma saru l- ebda studji li jinkludu pazjenti bi storja ta ’ tumuri malinni jew fejn tkompliet il- kura b’ Humira f’ pazjenti li jiżviluppaw tumuri malinni.
Thus additional caution should be exercised in considering Humira treatment of these patients (see section 4.8).
Għalhekk, wieħed għandu joqgħod aktar attent meta jikkunsidra l- kura b’ Humira ta’ dawn il- pazjenti (ara sezzjoni 4. 8).
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of non- melanoma skin cancer prior to and during treatment with Humira.
Il- pazjenti kollha, b’ mod speċjali dawk il- pazjenti li jkollhom storja medika ta ’ kura immunosoppressiva estensiva, jew pazjenti li jbatu bil- psorajiżi li jkollhom storja ta ’ kura PUVA, għandhom jiġu eżaminati qabel u matul il- kura b’ Humira biex isir magħruf jekk għandhomx kanċer tal- ġilda li m’ huwiex melanoma.
In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Fi prova klinika esploratorja li evalwat l- użu ta’ aġent ieħor għal kontra t- TNF, infliximab, f’ pazjenti li jbatu minn mard kroniku li jimblokka l- pulmun (COPD), minn moderat sa sever, ġew irrappurtati
All patients had a history of heavy smoking.
Il- pazjenti kollha kienu jpejpu ħafna.
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Għalhekk, għandha tiġi eżerċitata l- attenzjoni meta jintuża kwalukwe antagonist ta ’ TNF f’ pazjenti li jbatu minn COPD, kif ukoll f’ pazjenti li għandhom riskju akbar ta ’ tumur malinn minħabba li jpejpu ħafna.
Haematologic reactions
Reazzjonijiet ematoloġiċi
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF antagonists.
Rapporti rari ta ’ panċitopenja, inkluża anemija aplastika, ġew irrappurtati b’ antagonisti tat- TNF.
Adverse events of the haematologic system, including medically significant cytopoenia (e. g. thrombocytopaenia, leucopaenia) have been infrequently reported with Humira.
Effetti avversi tas- sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopaenia, lewkopenja) ma ġewx irrappurtati frekwentament b’ Humira.
Discontinuation of
Il- pazjenti kollha għandhom ikunu avżati biex ifittxu l- attenzjoni medika jekk jiżviluppaw sinjali u sintomi li jindikaw tibdil fil- livelli taċ- ċelloli tad- demm (eż deni persistenti, tbenġil, ħruġ ta ’ demm, sfurija) waqt li jkunu qegħdin jirċievu Humira.
7 Humira therapy should be considered in patients with confirmed significant haematologic abnormalities.
Għandu jiġi kkunsidrat it- twaqqif tal- kura b’ Humira f’ pazjenti li ġew kkonfermati li għandhom abnormalitajiet ematoloġiċi sinifikanti.
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Fi studju li sar fuq 226 suġġetti adulti li jbatu minn artrite rewmatika u li kienu kkurati b’ adalimumab jew bil- plaċebo, ġew osservati risponsi simili ta’ anti- korpi għat- tilqima b’ vaċċin stàndard 23- valent ta ’ newmokokku u t- tilqima tal- virus trivalenti ta ’ l- influwenza.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
M’ hawn l- ebda informazzjoni dwar it - trasmissjoni sekondarja ta ’ l- infezzjoni permezz ta ’ vaċċini ħajjin f’ pazjenti li jirċievu Humira.
It is recommended that polyarticular juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Hu rrakomandat li pazjenti b ’ artrite idjopatika poliartikulari taż- żagħżagħ, jekk jista ’ jkun, jieħdu t - tilqim kollu li jifdal skond il- pariri kurrenti ta ’ tilqim qabel ma jibdew il- kura b’ Humira.
Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Pazjenti li jkunu qegħdin fuq il- kura b’ Humira jistgħu jirċievu tilqim f’ daqqa, minbarra vaċċini ħajjin.
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Fi prova klinika li saret b’ antagonist ta ’ TNF ieħor, ġie osservat li l- insuffiċjenza tal- qalb konġestiva marret għall- agħar, u li minħabba l- insuffiċjenza tal- qalb konġestiva żdiedu l- imwiet.
Cases of worsening congestive heart failure have also been reported in patients receiving Humira.
Każi ta ’ fejn l - insuffiċjenza tal- qalb konġestiva marret għall- agħar ġew irrappurtati ukoll f’ pazjenti li jirċievu Humira.
Humira should be used with caution in patients with mild heart failure (NYHA class I/ II).
Humira għandu jintuża b’ attenzjoni f’ pazjenti li jbatu minn insuffiċjenza tal- qalb ħafifa (NYHA Klassi I/ II).
Humira is contraindicated in moderate to severe heart failure (see section 4.3).
Humira huwa kontro- indikat f’ pazjenti li jbatu minn insuffiċjenza tal- qalb minn moderata sa severa (ara sezzjoni 4. 3).
Treatment with Humira must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Il- kura b’ Humira għandha titwaqqaf f’ pazjenti li jiżviluppaw sintomi ġodda jew li jiggravawlhom is- sintomi eżistenti ta ’ insuffiċjenza tal- qalb konġestiva.
Autoimmune processes
Proċessi awtoimmuni
Treatment with Humira may result in the formation of autoimmune antibodies.
Il- kura b’ Humira tista ’ tirriżulta fil- formazzjoni ta’ anti- korpi awtoimmuni.
The impact of long- term treatment with Humira on the development of autoimmune diseases is unknown.
L- impatt tal- kura b ’ Humira fit- tul fuq l- iżvilupp ta ’ mard awtoimmuni m’ huwiex magħruf.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira and is positive for antibodies against double-stranded DNA, further treatment with Humira should not be given (see section 4.8).
Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis- sindromu tal- lupus wara li tkun ingħatat kura b’ Humira, u jkun pożittiv għall- anti- korpi kontra DNA li hi double stranded, m’ għandhiex tingħata aktar kura b’ Humira (ara sezzjoni 4. 8).
Concurrent administration of TNF-antagonists and anakinra
L- għoti flimkien ta ’ antagonisti ta ’ TNF u anakinra
Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Fi studji kliniċi fejn intużaw flimkien anakinra u antagonist ieħor ta ’ TNF, etanercept, ġew osservati infezzjonijiet serji, u ma kienx hemm żieda ta ’ xi benefiċju kliniku meta pparagunat ma ’ l- għoti ta ’ etanercept waħdu.
Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Minħabba n- natura ta ’ l- effetti avversi li ġew osservati bil- kura ta ’ etanercept u anakinra flimkien, tossiċitajiet simili jistgħu jirriżultaw ukoll ma ’ l- għoti ta ’ anakinra flimkien ma ’ antagonisti ta ’ TNF oħra.
(See section 4.5).
Għalhekk, l- għoti flimkien ta’ nadalimumab u anakinra m’ huwiex rrakkomandat (ara sezzjoni 4. 5).
Concurrent administration of TNF-antagonists and abatacept
8 L- għoti flimkien ta ’ antagonisti ta ’ TNF u abatacept
Concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
L- għoti flimkien ta ’ antagonisti ta ’ TNF u abatacept giet assoċjata ma żieda fir riskju ta ’ infezzjonijiet li jinkludu infezzjonijiet serji meta mqabbla ma antagonisti tat- TNF waħedhom, mingħajr ma jkun hemm żieda fit- titjib kliniku.
(See Section 4.5).
L- għoti flimkien ta ’ Humira ma abatacept mhux rakkomandat (ara sezzjoni 4. 5).
Surgery
Kirurġija
There is limited safety experience of surgical procedures in patients treated with Humira.
L- esperjenza ta ’ sigurtà ta ’ proċeduri kirurġiċi f’ pazjenti kkurati b’ Humira hija limitata.
The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned.
Jekk tkun ippjanata proċedura kirurġika, il- half life twila ta’ adalimumab għandha tiġi kkunsidrata.
A patient who requires surgery while on Humira should be closely monitored for infections, and appropriate actions should be taken.
Pazjent li jkollu bżonn operazzjoni waqt li jkun qiegħed jieħu Humira, għandu jiġi monitorjat mill- qrib għall - infezzjonijiet, u għandhom jittieħdu l- azzjonijiet xierqa.
There is limited safety experience in patients undergoing arthroplasty while receiving Humira.
L- esperjenza ta ’ sigurtà f’ pazjenti li jiġu operati biex jinbidlulhom il- ġogi waqt li jkunu qegħdin jirċievu Humira hija limitata.
8 Small bowel obstruction
Imblukkar tal- musrana ż- żgħira
Failure to respond to treatment for Crohn’ s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Il- fatt li ma jkunx hemm rispons għall- kura tal- marda Crohn (Crohn’ s disease) jista ’ jindika l - preżenza ta ’ kontrazzjoni fissa riżultat ta ’ fibrożi u jista ’ jkun li jkun hemm bżonn ta ’ kura kirurġika.
Available data suggest that Humira does not worsen or cause strictures.
Informazzjoni li għandna turi li Humira ma tikkaġunax kontrazzjonijiet eżistenti biex imorru għall - agħar, u lanqas ma tikkawżahom.
Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate.
Humira ġie studjat f’ pazjenti li jbatu bl- artrite rewmatika, b’ artrite idjopatika poliartikulari taż - żagħżagħ u bl- artrite psorjatika li jieħdu Humira waħdu bħala kura, kif ukoll f’ dawk li jieħdu methotrexate flimkien ma ’ Humira.
Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.
Il- formazzjoni ta ’ anti- korpi kienet iktar baxxa meta Humira ingħata flimkien ma ’ methotrexate, meta pparagunat ma ’ l- użu ta ’ Humira waħdu bħala kura.
Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
L- għoti ta ’ Humira mingħajr methotrexate rriżulta f’ żieda fil- formazzjoni ta’ anti- korpi, żieda fit - tneħħija u tnaqqis fl- effikaċja ta ’ adalimumab (ara sezzjoni 5. 1).
The combination of Humira and anakinra is not recommended (see section 4.4 “ Concurrent administration of TNF-antagonists and anakinra”).
L- għoti flimkien ta ’ Humira ma anakinra mhux rakkomandat (ara sezzjoni 4. 4 “ L- għoti flimkien ta ’ antagonisti ta ’ TNF u anakinra ”).
The combination of Humira and abatacept is not recommended (see section 4.4 “ Concurrent administration of TNF-antagonists and abatacept”).
L- għoti flimkien ta ’ Humira ma abatacept mhux rakkomandata (ara sezzjoni 4. 4 “ L- għoti flimkien ta ’ antagonisti ta ’ TNF u abatacept ”).
For Humira, no clinical data on exposed pregnancies are available
Għall- Humira m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Fi studju dwar it- tossiċità fl- iżvilupp li sar fuq ix- xadini, ma kien hemm l- ebda indikazzjoni ta ’ tossiċità fl- omm, fl- embriju jew ta ’ teratoġeniċità.
Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3).
Informazzjoni qabel il- prodott tpoġġa fuq is- suq dwar it- tossiċità wara t- twelid u l- effetti ta’ adalimumab fuq il- fertilità m’ humiex disponibbli (ara sezzjoni 5. 3).
Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Minħabba li adalimumab jimpedixxi t- TNFα, it- teħid tiegħu waqt it- tqala jista ’ jaffetwa r- risponsi immuni normali tat- tarbija tat- twelid.
Administration of adalimumab is not recommended during pregnancy.
It- teħid ta ’ adalimumab waqt it- tqala m’ huwiex rrakkomandat.
Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv biex jevitaw it- tqala, u jibqgħu jużawh sa mill- inqas ħames xhur wara l- aħħar trattament ta ’ Humira.
It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
M’ huwiex magħruf jekk adalimumab joħroġx mill- ħalib uman jew jekk jiġix assorbit b’ mod sistemiku wara li jittieħed.
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Humira treatment.
Madanakollu, minħabba li l- immunoglobulini umani joħorġu mill- ħalib, in- nisa m’ għandhomx ireddgħu għal mill- inqas ħames xhur wara l- aħħar trattament ta ’ Humira.
4.7 Effects on ability to drive and use machines
9 Effetti fuq il- ħila biex issuq u tħaddem magni 4. 7
Humira may have a minor influence on the ability to drive and use machines.
Humira jista ’ jkollu effett zgħir fuq il- ħila biex issuq u tħaddem magni.
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Humira (see Section 4.8)
Jista jkun hemm sturdament (li jinkludi vertigo disturbi fil- vista u għejja) wara li tingħata Humira (ara sezzjoni 4. 8).
4.8 Undesirable effects
Effetti mhux mixtieqa 4. 8
Clinical Trials
Provi Kliniċi
Humira was studied in 6593 patients in controlled and open label trials for up to 60 months.
Humira ġie studjat f’ 6, 593 pazjent fi provi kontrollati u open- label li damu sejrin sa 60 xahar.
These trials included rheumatoid arthritis patients with short term and long standing disease, polyarticular juvenile idiopathic arthritis as well as psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis patients.
Dawn il - provi inkludew pazjenti li jbatu minn artrite rewmatika, kemm f’ dawk li ma jkunux ilhom u dawk li jkunu ilhom bil- marda, f’ artrite idjopatika poliartikulari taż- żagħżagħ kif ukoll pazjenti li jbatu minn artrite psorjatika, minn infjammazzjoni tal- vertebri li jirriżulta fil- vertebri jitwaħħlu flimkien (ankylosing spondylitis), mill- marda Crohn (Crohn’ s disease) u mill- psorajiżi.
The data in Table 1 is based on the pivotal controlled Studies involving 4,355 patients receiving Humira and 2,487 patients receiving placebo or active comparator during the controlled period.
L- informazzjoni f’ Tabella 1 hija bbażata fuq l- Istudji pivitali kontrollati li nvolvew 4, 355 pazjent li kienu qegħdin jirċievu Humira u 2, 487 pazjent li kienu qegħdin jirċievu l- plaċebo jew sustanza attiva li l- effetti tagħħa tista ’ titqabbel ma ’ Humira, matul il- perijodu kontrollat.
9 The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 4.5% for patients taking Humira and 4.5% for control treated patients.
Il- proporzjon ta ’ pazjenti li waqt il- porzjoni kontrollata double- blind fl- istudji pivitali ma baqgħux jieħdu l- kura minħabba effetti avversi kien ta ’ 4. 6% għall- pazjenti li kienu qegħdin jieħdu Humira u 4. 6% għal pazjenti kkurati b’ mod kontrollat.
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Effetti mhux mixtieqa f’ pazjenti pedjatriċi b’ artrite idjopatika poliartikulari taż- żagħżagħ
In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
B’ mod ġenerali, l- effetti avversi f’ pazjenti pedjatriċi kellhom frekwenza u t- tip simili għal dawk li ġew osservati f’ pazjenti adulti.
Adverse events at least possibly causally-related to adalimumab for pivotal studies, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100 and rare ≥ 1/ 10,000 to < 1/ 1,000) in Table 1 below.
Effetti avversi għal studji pivitali, kemm kliniċi u tal- laboratorju, li mill- inqas huma relatati każwalment ma’ adalimumab, huma mniżżla skond il- klassi tas- sistema ta ’ l- organu u l- frekwenza (komuni ħafna ≥ 1/ 10; komuni ≥ 1/ 100 sa < 1/ 10; mhux komuni ≥ 1/ 1, 000 sa < 1/ 100 u rari ≥ 1/ 10, 000 sa < 1/ 1, 000) f’ Tabella 1 hawn taħt.
Table 1 Undesirable Effects in Clinical Studies
Tabella 1 Effetti mhux Mixtieqa fi Studji Kliniċi
System Organ Class Investigations
Klassi tas- Sistema ta ’ l - Organu
Frequency Uncommon
Frekwenza
Adverse Reaction blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
Reazzjoni Avversa żieda fil- livell tal- creatine phosphokinase fid -
Cardiac disorders
Investigazzjonijiet
arrhythmias, tachycardia
demm, żieda fil- ħin thromboplastin attivat parzjali, preżenza ta ’ anti- korpi pproduċuti mill - ġisem għal kontrih stess
Rare
tħabbit irregolari tal- qalb, takikardija Mhux Disturbi fil- qalb Komuni
cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion, congestive cardiac failure, palpitations
attakk tal- qalb, insuffiċjenza ta ’ l- arterja Rari koronarja, anġina pectoris, effużjoni tal - perikardju, insuffiċjenza tal- qalb konġestiva, palpitazzjonijiet
Blood and the lymphatic system disorders
10 newtropenja (li tinkludi agranulocytosis), Mhux Disturbi tad- demm u tas - lewkopenja, thrombocytopaenia, anemija, mard Komuni sistema limfatika fil- limfa, lewkoċitosi, limfopenja
Uncommon
panċitopenja, purpura idjopatika Rari thrombocytopaenic sturdament (li jinkludi vertigo), uġigħ ta ’ ras, Komuni Disturbi fis- sistema nervuża disturbi fis- sensazzjoni newroloġika (li jinkludu parasteżija)
neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, lymphadenopathy, leucocytosis, lymphopaenia
sinkope, migranja, tregħid, disturbi fl- irqad Mhux Komuni
pancytopaenia, idiopathic thrombocytopaenic purpura
sklerosi multipla, paralisi tal- wiċċ
Nervous system disorders
Disturbi fl- għajnejn
dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
disturbi fil- vista, disturbi fis- sensazzjoni ta ’ l - għajnejn, infezzjoni, irritazzjoni jew infjammazzjoni ta ’ l- għajn
syncope, migraine, tremor, sleep disturbances
panophthalmitis, infjammazzjoni tal- ħabba ta ’ l - Rari għajn, glawkoma
Eye disorders
Disturbi fil- widnejn u fis -
Rare
Mhux
10 System Organ Class Ear and labyrinth disorders
skonfort fil- widnejn (li jinkludi uġigħ u nefħa)
Frequency Uncommon
sistema labirintika
Rare
Komuni Rari
hearing loss, tinnitus
telf ta’ smiegħ, żanżin fil- widnejn
Common
Komuni Mhux Komuni
asthma, dyspnoea, dysphonia, nasal congestion
sogħla, uġigħ rinofarinġali ażżma, qtugħ ta ’ nifs, tnaqqis jew telf ta ’ vuċi, konġestjoni fl- imnieħer
pulmonary oedema, pharyngeal oedema, pleural effusion, pleurisy
nefħa fil- pulmun minn akkumulazzjoni ta ’ ilma, nefħa fil- farinġi minn akkumulazzjoni ta ’ ilma, effużjoni tal- plewra, plewrite dijarea, uġigħ addominali, stomatite u ulċeri fil -
diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea
emorraġija fir- rektum, rimettar, dispepsja, nefħa Mhux
Uncommon
Komuni
rectal haemorrhage, vomiting, dyspepsia, abdominal bloating, constipation
addominali, stitikezza
pancreatitis, intestinal stenosis, colitis, enteritis, oesophagitis, gastritis
pankreatite, stenosi ta ’ l- intestini, kolite, enterite, esofaġite, gastrite
Renal and urinary disorders
Disturbi fil- kliewi u fis -
haematuria, renal impairment, bladder and urethral symptoms
ematurja, indeboliment renali, sintomi fil - bużżieqa ta ’ l- awrina u fl- uretra
proteinuria, renal pain
proteinuria, uġigħ renali Rari
rash, pruritus
raxx, ħakk
urticaria, psoriasis, ecchymosis and increased bruising, purpura, dermatitis and eczema, hair loss
11 urtikarja, psorajiżi, tbenġil minħabba ħruġ ta ’ Mhux demm minn vini zgħar u tbenġil aktar malajr, Komuni purpura, dermatite u ekżema, taqa ’ ix- xagħar
erythema multiforme, panniculitis
eritema tat- tip mutiforme, panniculitis
Musculoskeletal, connective tissue and
uġigħ muskoskeletrali Disturbi muskolu- skeletrali, tal- connective tissue u ta ’ l - għadam
Common
Komuni Rari
musculoskeletal pain
Rabdomijoliżi Disturbi fit- tirojde (li jinkludi għanqra)
bone disorders
Disturbi fis- sistema endokrinarja
Endocrine disorders
Disturbi fil- metaboliżmu u n -
thyroid disorder (including goitre)
hypokalaemia, żieda fil- lipidi, disturbi fl- aptit (li jinkludu anoressija), livelli ta ’ ureja għoljin fid -
Metabolism and nutrition disorders
nutrizzjoni
hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
demm
hypercalcaemia, hypocalcaemia
hypercalcaemia, hypocalcaemia
11 System Organ Class Infections and infestations
infezzjonijiet fin- naħa ta ’ isfel tas- sistema Infezzjonijiet u impestazzjonijiet
Frequency Common
Komuni
Adverse Reaction lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection
respiratorja (inklużi pnewmonja, bronkite), infezzjonijiet virali (li jinkludu l- influwenza, infezzjonijiet ta ’ l- erpete), candidiasis, infezzjonijiet tal- batterji (li jinkludu infezzjonijiet fis- sistema urinarja), infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja
opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
sepsis, infezzjonijiet opportunistiċi (li jinkludu t -
necrotising fasciitis, viral meningitis, diverticulitis, wound infection
tuberkulosi, histoplasmosis), axxess, infezzjoni tal- ġogi, infezzjoni tal- ġilda (inklużi infjammazzjoni tas- tessuti ċellulari u impetiġini), infezzjonijiet tal- fungu superfiċjali (li jinkludu l- ġilda, id- difer u s- sieq)
Injury and poisoning
faxxite bin- nekrosi, meninġite virali, Rari infjammazzjoni tad- divertikulu, infezzjoni tal - ferita
Uncommon
korriment aċċidentali, fejqan jieħu iżjed fit- tul Korriment u avvelenament
accidental injury, impaired healing
Mhux Komuni
Neoplasms benign, malignant and unspecified
Neoplażmi beninni, malinni u
skin papilloma
tumur tal- ġilda beninn
(including cysts and polyps)
mhux speċifikati (inklużi ċesti u polipi)
lymphoma, solid organ tumours (including breast, ovarian, testicular), malignant melanoma, squamous cell carcinoma of the skin
limfoma, tumuri fl- organi solidi (li jinkludu tumur fis- sider, tumur fl- ovarji, tumur testikulari), melanoma malinn, karċinoma tal - ġilda biċ- ċelluli tat- tip squamous
hypertension, flushing, haematoma
ematoma
vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm
sadd fil- vini, stenosi ta ’ l- aorta, thrombophlebitis, anewriżma ta ’ l- aorta
General disorders and administration site conditions
12 Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Very Common
Komuni Ħafna Komuni
injection site reaction (including pain, swelling, redness or pruritus)
reazzjoni fil- post ta ’ l- injezzjoni (li tinkludi uġigħ, nefħa, ħmura jew ħakk) deni, għejja (li jinkludi astenja u telqa tal- ġisem mingħajr l- ebda sinjali ta ’ mard)
pyrexia, fatigue (including asthenia and malaise)
uġigħ fis- sider, edema, mard li jkun qisu influwenza
chest pain, oedema, influenza like illness
systemic lupus erythematosus, anġjoedema, Disturbi fis- sistema immuni
systemic lupus erythematosus, angioedema, drug hypersensitivity
sensittività eċċessiva għall- mediċina
serum sickness, seasonal allergy
marda tas- serum, allerġija assoċjata ma ’ l - istaġuni
hepatic enzymes increased
żieda fl- enzimi tal- fwied
hepatic necrosis, hepatitis, hepatic steatosis, cholelithiasis, blood bilirubin increased
nekrosi tal- fwied, epatite, stejatożi epatika, formazzjoni ta ’ ġebel fil- marrara, żieda fil - bilirubina fid- demm
Reproductive system and breast disorders
disturbi fiċ- ċiklu tal- mestrwazzjoni u fil- mod kif Disturbi fis- sistema
menstrual cycle and uterine bleeding disorders
joħroġ id- demm mill- utru
mood disorders, anxiety (including nervousness and agitation)
disturbi fil- burdata, ansjetà (inklużi nervożità u aġitazzjoni)
12 Injection site reactions
Reazzjonijiet fil- post ta ’ l- injezzjoni