qanastek/EMEA-V3 huggingface dataset:
The safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated (see section 4.4).
Is- sigurtà u l- effikaċja ta ’ STELARA flimkien ma ’ immunosoppressanti oħra, inklużi prodotti bijoloġiċi, jew fototerapija ma ġewx evalwati (ara sezzjoni 4. 4).
Pregnancy There are no adequate data from the use of ustekinumab in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ ustekinumab waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara t - twelid (ara sezzjoni 5. 3).
As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.
Bħala miżura ta ’ prekawzjoni, huwa preferibbli li l- użu ta ’ STELARA jiġi evitat fit- tqala.
Women of childbearing potential should use effective methods of contraception during treatment and up to 15 weeks after treatment.
Nisa f’ età li jista ’ jkollhom it- tfal għandhom jużaw metodi effettivi ta ’ kontraċezzjoni waqt il- kura u sa 15- il ġimgħa wara l- kura.
4 Lactation It is unknown whether ustekinumab is excreted in human breast milk.
Treddigħ M’ huwiex magħruf jekk ustekinumab joħroġx mal- ħalib tas- sider tal- omm.
Animal studies have shown excretion of ustekinumab at low levels in breast milk.
Studji fl- annimali urew li kien hemm livelli baxxi ta ’ ustekinumab fil- ħalib tas- sider.
It is not known if ustekinumab is absorbed systemically after ingestion.
M’ huwiex magħruf jekk ustekinumab jiġix
Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
Minħabba r- reazzjonijiet avversi li jista ’ jkun hemm minn ustekinumab fi trabi li qed jieħdu l- ħalib tas- sider, id- deċiżjoni dwar jekk jitwaqqafx it- treddigħ waqt il- kura bi STELARA u sa 15- il ġimgħa wara l- kura, jew jitwaqqafx STELARA għal kollox għandha ssir billi jiġi kkunsidrat il- benefiċċju li qed tieħu t- tarbija mit- treddigħ u l- benefiċċju li se tieħu l- mara mill- kura bi STELARA.
No studies on the effects on the ability to drive and use of machines have been performed.
Ma saru l- ebda studji dwar l- effetti fuq il- ħila li ssuq u tħaddem magni.
The safety data described below reflect exposure to ustekinumab in 3 studies of 2,266 patients, including 1,970 exposed for at least 6 months and 1,285 exposed for at least 1 year, and 373 for at least 18 months.
It- tagħrif ta ’ sigurtà deskritt hawn taħt jirifletti esponiment għal ustekinumab fi 3 studji ta ’ 2, 266 pazjent, inkluż 1, 970 esposti għal mill- anqas 6 xhur u 1, 285 esposti għal mill- anqas sena, u 373 għal mill- anqas 18- il xahar.
The following serious adverse reactions were reported: • Serious infections • Malignancies
Ir- reazzjonijiet avversi serji li ġejjin kienu rrappurtati: • Infezzjonijiet serji • Tumuri malinni
The most common adverse reactions (> 10%) in controlled and uncontrolled portions of the psoriasis clinical studies with ustekinumab were nasopharyngitis and upper respiratory tract infection.
L- aktar reazzjonijiet avversi komuni (> 10%) fi fażijiet ikkontrollati u mhux ikkontrollati ta ’ l- istudji kliniċi tal- psorijasi b’ ustekinumab kienu nażofarinġite u infezzjoni tan- naħa ta ’ fuq ta ’ l- apparat tan - nifs.
Most were considered to be mild and did not necessitate discontinuation of study treatment.
Il- biċċa l- kbira kienu kkunsidrati ħfief u ma kienx hemm bżonn li titwaqqaf il- kura tul l- istudju.
Table 1 provides a summary of adverse reactions from psoriasis clinical studies.
Tabella 1 tagħti sommarju tar- reazzjonijiet avversi mill- istudji kliniċi tal- psorijasi.
The adverse reactions are classified by System Organ Class and frequency, using the following convention:
Ir- reazzjonijiet avversi huma kklassifikati skont is- Sistema tal- Klassifika tal- Organi u l- frekwenza bl- użu tal - konvenzjoni li ġejja:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000), Very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Komuni ħafna (≥ 1/ 10), Komuni (≥ 1/ 100 sa < 1/ 10), Mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), Rari (≥ 1/ 10, 000 sa < 1/ 1, 000), Rari ħafna (< 1/ 10, 000), mhux magħrufa (ma jistgħux jiġu stmati mit- tagħrif disponibbli).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skont is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Table 1 Summary of adverse reactions in psoriasis clinical studies System Organ Class
Tabella 1 Sommarju tar- reazzjonijiet avversi fl- istudji kliniċi tal- psorijasi Sistema tal- Klassifika tal- Organi
Frequency:
Frekwenza:
Upper respiratory tract infection, nasopharyngitis Common:
Infezzjoni fin- naħa ta ’ fuq tal- apparat tan- nifs, nażofarinġite Komuni:
Cellulitis, viral upper respiratory tract infection
Ċellulite, infezzjoni virali fin- naħa ta ’ fuq tal- apparat tan- nifs
Depression
Depressjoni
Dizziness, headache
Sturdament, uġigħ ta ’ ras
Pharyngolaryngeal pain, nasal congestion
Uġigħ tal- larinġi u l- farinġi, konġestjoni nażali
Musculoskeletal and connective tissue disorders
Disturbi muskolo- skeltrali u tal- connective tissue
Back pain, myalgia
Uġigħ fid- dahar, majalġja
Fatigue, injection site erythema Uncommon:
Għeja kbira, eritema fis- sit ta ’ l- injezzjoni Mhux komuni:
Injection site reactions (including pain, swelling, pruritus, induration, haemorrhage, bruising and irritation)
Reazzjonijiet fis- sit ta ’ l- injezzjoni (li jinkludi uġigħ, nefħa, ħakk, ebusija, emorraġija, tbenġil u irritazzjoni)
5 Infections In controlled studies of psoriasis patients, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
5 Infezzjonijiet Fi studji kkontrollati ta ’ pazjenti bil- psorijasi, ir- rati ta ’ infezzjonijiet jew infezzjonijiet serji kienu jixtiebhu bejn pazjenti kkurati b’ ustekinumab u dawk ikkurati bi plaċebo.
In the placebo-controlled period of clinical studies of psoriasis patients, the rate of infection was 1.39 per patient-year of follow-up in ustekinumab-treated patients, and 1.21 in placebo-treated patients.
Fl- istudji kliniċi ta ’ pazjenti bil- psorijasi, fil- perijodu kkontrollat bi plaċebo, ir- rata ta ’ infezzjoni kienet ta ’ 1. 39 għal kull sena ta ’ sorveljanza wara l- kura ta ’ pazjent fil- pazjenti kkurati b’ ustekinumab u 1. 21 fil- pazjenti kkurati bi plaċebo.
Serious infections occurred in 0.01 per patient-year of follow-up in ustekinumab-treated patients (5 serious infections in 407 patient-years of follow-up) and 0.02 in placebo-treated patients (3 serious infections in 177 patient-years of follow-up) (see section 4.4).
Infezzjonijiet serji tfaċċaw f’ 0. 01 għal kull sena ta ’ sorvelajanza wara l- kura ta ’ pazjent fil - pazjenti kkurati b’ ustekinumab (5 infezzjonijiet serji f’ 407 snin ta ’ sorveljanza wara l- kura ta ’ pazjent) u 0. 02 fil- pazjenti kkurati bi plaċebo (3 infezzjoniiet serji f’ 177 sena ta ’ sorveljanza wara l- kura ta’ pazjent) (ara sezzjoni 4. 4).
In the controlled and non-controlled portions of psoriasis clinical studies, the rate of infection was 1.24 per patient-year of follow-up in ustekinumab-treated patients, and the incidence of serious infections was 0.01 per patient-year of follow-up in ustekinumab-treated patients (24 serious infections in 2,251 patient-years of follow-up) and serious infections reported included cellulitis, diverticulitis, osteomyelitis, viral infections, gastroenteritis, pneumonia, and urinary tract infections.
Fil- porzjonijiet tal- istudji kliniċi tal- psorijasi kkontrollati u mhux ikkontrollati, ir- rata ta ’ infezzjoni kienet 1. 24 għal kull sena ta ’ sorveljanza wara l- kura ta ’ pazjent fil- pazjenti kkurati b’ ustekinumab, u l- inċidenza ta ’ infezzjonijiet serji kienet ta ’ 0. 01 għal kull sena ta ’ sorvelajanza wara l- kura ta ’ pazjent fil- pazjenti kkurati b’ ustekinumab (24 infezzjoni serja f’ 2, 251 sena ta ’ sorveljanza wara l- kura ta ’ pazjenti) u infezzjonijiet serji rrapportati kienu jinkludu ċellulite, divertikulite, ostejomijelite, infezzjonijiet virali, gastroenterite, pulmonite u infezzjonijiet fl- apparat ta ’ l- awrina.
In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis.
Fl- istudji kliniċi, pazjenti b’ tuberkulosi mhux attiva li fl- istess ħin kienu kkurati b’ isoniazid ma żviluppawx tuberkulosi.
Malignancies In the placebo-controlled period of the psoriasis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.25 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 406 patient-years of follow-up) compared with 0.57 for placebo-treated patients (1 patient in 177 patient-years of follow-up).
Tumuri malinni Fil- perijodu ta ’ l- istudji kliniċi tal- psorijasi kkontrollat bi plaċebo, l- inċidenza ta ’ tumuri malinni minbarra kanċer tal- ġilda li mhux melanoma, kienet ta ’ 0. 25 għal kull 100 sena ta ’ sorveljanza wara l - kura ta ’ pazjent għall- pazjenti kkurati b’ ustekinumab (pazjent wieħed f’ 406 snin ta ’ sorveljanza wara l- kura ta ’ pazjenti) meta mqabbla ma ’ 0. 57 għall- pazjenti kkurati bi plaċebo (pazjent wieħed f’ 177 sena ta ’ sorveljanza wara l- kura ta ’ pazjent).
The incidence of non-melanoma skin cancer was 0.74 per 100 patient-years of follow-up for ustekinumab-treated patients (3 patients in 406 patient-years of follow-up) compared to 1.13 for placebo-treated patients (2 patients in 176 patient-years of follow-up).
L- inċidenza ta ’ kanċer tal- ġilda li mhux melanoma kien ta ’ 0. 74 għal kull 100 sena ta ’ pazjent għal pazjenti kkurati b’ ustekinumab (3 pazjenti f’ 406 snin ta ’ sorveljanza wara l- kura ta ’ pazjent) meta mqabbla ma ’ 1. 13 għal pazjenti kkurati bi plaċebo (2 pazjenti f’ 176 sena ta ’ sorveljanza wara l- kura ta ’ pazjent).
In the controlled and non-controlled portions of psoriasis clinical studies, the incidence of malignancies excluding non-melanoma skin cancers was 0.36 per 100 patient-years of follow-up for ustekinumab-treated patients (8 patients in 2,249 patient-years of follow-up) and malignancies reported included breast, colon, head and neck, kidney, prostate, and thyroid cancers.
Fil- partijiet ta ’ l- istudji kliniċi tal- psorijasi kkontrollati u mhux ikkontrollati, l- inċidenza ta ’ tumuri malinni minbarra l- kankri tal- ġilda li m’ humiex melanoma kienet ta ’ 0. 36 għal kull 100 sena ta ’ sorveljanza wara l- kura ta ’ pazjent għal pazjenti kkurati b’ ustekinumab (8 pazjenti f’ 2, 249 sena ta ’ sorveljanza wara l- kura ta ’ pazjent) u tumuri malinni rrapportati kienu jinkludu kankri tas- sider, tal - musrana l- kbira tar- ras, ta ’ l- għonq, tal- kliewi, tal- prostata u tat- tirojde.
The rate of malignancies reported in ustekinumab-treated patients was comparable to the rate expected in the general population (standardised incidence ratio = 0.68 [95% confidence interval:
(proporzjon standardizzat ta ’ inċidenza 0. 68 [95% confidence interval:
The incidence of non-melanoma skin cancer was 0.80 per 100 patient-years of follow-up for ustekinumab-treated patients (18 patients in 2,245 patient-years of follow-up) (see section 4.4).
L - inċidenza ta ’ kanċer tal- ġilda li m’ huwiex melanoma kien ta ’ 0. 80 għal kull 100 sena ta ’ sorveljanza wara l- kura ta ’ pazjent għal pazjenti kkurati b’ ustekinumab (18- il pazjent f’ 2, 245 sena ta ’ sorveljanza wara l- kura ta ’ pazjent) (ara Sezzjoni 4. 4).
Hypersensitivity reactions In clinical studies of ustekinumab, rash and urticaria have each been observed in < 2% of patients.
Reazzjonijiet ta ’ sensittività eċċessiva Fl- istudji kliniċi ta ’ ustekinumab, kemm raxx u kemm urtikarja kienu osservati f ’ < 2% tal- pazjenti.
Immunogenicity Approximately 5% of ustekinumab-treated patients developed antibodies to ustekinumab, which were generally low-titer.
Immunoġeniċità Bejn wieħed u ieħor 5% tal- pazjenti kkurati b’ ustekinumab żviluppaw antikorpi għal ustekinumab, li ġeneralment kienu ta ’ titer baxx.
No apparent correlation of antibody development to injection site reactions was seen.
Ma dehret l- ebda evidenza ta ’ korrelazzjoni bejn l- żvilupp ta ’ antikorpi u reazzjonijiet fis- sit tal- injezzjoni.
Efficacy tended to be lower in patients positive for antibodies to ustekinumab; however, antibody positivity does not preclude a clinical response.
L- effikaċja kellha tendenza li tkun aktar baxxa f’ pazjenti pożittivi għal antikorpi għal ustekinumab; madankollu, pożittività għal antikorpi ma ’ tfixkilx ir - rispons kliniku.
No cases of overdose have been reported.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat.
Single doses up to 4.5 mg/ kg have been administered intravenously in clinical studies without dose-limiting toxicity.
6 Dożi waħdiet sa 4. 5 mg/ kg ingħataw ġol- vina fi studji kliniċi mingħajr tossiċità li tillimita d- doża.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
F’ każ ta ’ doża eċċessiva, huwa rrakkomandat li l- pazjent jiġi mmonitorjat għal xi sinjali jew sintomi ta ’ reazzjonijiet avversi u kura xierqa tas- sintomi għandha tinbeda immedjatament.
Interleukin inhibitors, ATC code:
Kodiċi ATC:
Mechanism of action Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit of the human cytokines IL-12 and IL-23.
Kif jaħdem Ustekinumab huwa antikorp monoklonali IgG1κ kollu kemm hu uman li jeħel b’ affinità u speċifiċità kbira mas- sottoparti tal- proteina p40 tas- cytokines umani IL- 12 u IL- 23.
Ustekinumab inhibits the activity of human IL-12 and IL-23 by preventing these cytokines from binding to their IL-12Rβ 1 receptor protein expressed on the surface of immune cells.
Ustekinumab jimpedixxi l - attività tal- IL- 12 u IL- 23 umani billi ma jħallix dawn is- cytokines jeħlu mal- proteina riċettur tagħhom IL- 12Rβ1 espress fuq il- wiċċ taċ- ċelloli immuni.
Ustekinumab cannot bind to IL-12 or IL-23 that is pre-bound to IL-12Rβ 1 cell surface receptors.
Ustekinumab ma jistax jeħel mal- IL- 12 jew IL- 23 li huma diġà marbutin mar- riċetturi IL- 12Rβ fuq il- wiċċ taċ- ċellola.
Thus, ustekinumab is not likely to contribute to complement- or antibody-mediated cytotoxicity of the receptor-bearing cell.
B’ hekk, ustekinumab x’ aktarx ma jikontribwixxix għal ċitotossiċità medjata minn komplement jew antikorp taċ- ċellola li fiha r- riċettur.
IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells.
IL- 12 u IL- 23 huma cytokines eterodimeriċi li mnixxija minn ċelloli attivati li jippreżentaw l- antiġen, bħal ma huma l- makrofaġi u ċ- ċelloli tad- dendrite.
IL-12 and IL-23 participate in immune function by contributing to natural killer (NK) cell activation and CD4+ T-cell differentiation and activation.
IL- 12 u IL- 23 jipparteċipaw fil- funzjoni immuni billi jikkontribwixxu għall- attivazzjoni taċ- ċellola natural killer NK u d- divrenzjar u l- attivazzjoni taċ - ċellola- T CD4+.
However, abnormal regulation of IL-12 and IL-23 has been associated with immune-mediated diseases, such as psoriasis.
Madankollu, regolazzjoni mhux normali ta ’ IL- 12 u IL- 23 kienet assoċjata ma ’ mard li jinvolvi s- sistema immuni, bħal ma hija l- psorijasi.
Ustekinumab prevents IL-12 and IL-23 contributions to immune cell activation, such as intracellular signaling and cytokine secretion.
Ustekinumab ma jħallix li IL- 12 u IL- 23 jikkontribwixxu għal attivazzjoni taċ- ċelloli immuni, pereżempju permezz ta ’ sinjali intraċellulari u jnixxu is- cytokine.
Thus, ustekinumab is believed to interrupt signaling and cytokine cascades that are relevant to psoriasis pathology.
B’ hekk, huwa mifhum li ustekinumab ifixkel is- sinjali u l- kaskati tas- cytokines li huma rilevanti għall- patoloġija tal- psorijasi.
Clinical efficacy and safety The safety and efficacy of ustekinumabwas assessed in 1,996 patients in two randomised, double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who were candidates for phototherapy or systemic therapy.
Effikaċja klinika u sigurtà Is- sigurtà u l- effikaċja ta ’ ustekinumab kienet stmata f’ 1, 996 pazjent f’ żewġ studji, randomised, double- blind, ikkontrollati bi plaċebo f’ pazjenti bi psorijasi bil- qoxra minn moderata sa qawwija u li kienu kandidati għal fototerapija jew kura sistemika.
Psoriasis Study 1 (PHOENIX 1) evaluated 766 patients.
L- istudju tal- Psorijasi 1 (PHOENIX 1) evalwa 766 pazjent.
53% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
53% ta ’ dawn il- pazjenti ma rrispondewx, jew kienu intolleranti jew kellhom kontraindikazzjoni għal kura sistemka oħra.
Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 and followed by the same dose every 12 weeks.
Pazjenti randomised għal ustekinumab ingħataw dożi ta ’ 45 mg jew 90 mg fil- Ġimgħat 0 u 4 u komplew bl- istess doża kull 12- il ġimgħa.
Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16 followed by dosing every 12 weeks.
Pazjenti randomised biex jirċievu plaċebo fil- Ġimgħat 0 u 4 qalbu għal ustekinumab (45 mg jew 90 mg) fil- Ġimgħat 12 u 16 u komplew bl- istess doża kull 12- il ġimgħa.
Patients originally randomised to ustekinumab who achieved Psoriasis Area and Severity Index 75 response (PASI improvement of at least 75% relative to baseline) at both Weeks 28 and 40 were re-randomised to receive ustekinumab every 12 weeks or to placebo (i. e., withdrawal of therapy).
Pazjenti li oriġinarjament kienu randomised għal ustekinumab li kisbu rispons ta ’ 75 fuq l- Indiċi tal- Parti Milquta mill- Psorijasi u l- Qawwa tagħha (PASI) (PASI titjib ta ’ mill- anqas 75% relattiv għall- linja bażi) kemm fil- Ġimgħa 28 kif ukoll fil- Ġimgħa 40 kienu randomised mill- ġdid biex jingħataw ustekinumab kull 12- il ġimgħa jew plaċebo (i. e., twaqqif tal- kura).
Patients who were re-randomised to placebo at Week 40 reinitiated ustekinumab at their original dosing regimen when they experienced at least a 50% loss of their PASI improvement obtained at Week 40.
Pazjenti li kienu randomised mill- ġdid għall- plaċebo fil- Ġimgħa 40 reġgħu bdew ustekinumab fid- doża oriġinali li kellhom, meta esperjenzaw telf ta ’ mill - anqas 50% mit- titjib PASI li kienu kisbu fil- Ġimgħa 40.
All patients were followed for up to 76 weeks following first administration of study treatment.
Il- pazjenti kollha kienu segwiti sa 76 ġimgħa minn meta ngħatat il- kura fl- istudju għall- ewwel darba.
Psoriasis Study 2 (PHOENIX 2) evaluated 1230 patients.
L- istudju tal- Psorijasi 2 (PHOENIX 2) evalwa 1, 230 pazjent.
61% of these patients were either non- responsive, intolerant, or had a contraindication to other systemic therapy.
61% minn dawn il- pazjenti ma rrispondewx, jew kienu intolleranti jew kellhom kontraindikazzjoni għal kura sistemika oħra.
Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 followed by an additional dose at 16 weeks.
Pazjenti randomised għal ustekinumab rċievew dożi ta ’ 45 mg jew 90 mg fil- Ġimgħat 0 u 4 segwiti minn doża addizzjonali fis- 16- il ġimgħa.
Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.
Pazjenti randomized biex jirċievu plaċebo fil- Ġimgħat 0 u 4 qalbu għall - fergħa l- oħra tal- istudju u bdew jirċievu ustekinumab (45 mg jew 90 mg) fil- Ġimgħat 12 u 16.
All patients were followed for up to 52 weeks following first administration of study treatment.
Il - pazjenti kollha kienu segwiti sa 52 ġimgħa minn meta ngħata t- trattament tal- istudju għall- ewwel darba.
In both studies, baseline disease characteristics were generally consistent across all treatment groups with a median baseline PASI score from 17 to 18 and median baseline Body Surface Area (BSA) ≥ 20, median Dermatology Life Quality Index (DLQI) range from 10 to 12.
Fiż- żewġ studji, il- karatteristiċi tal- marda fil- linja bażi kienu b’ mod ġenerali konsistenti f’ kull grupp ta ’ kura b’ linja bażi medjana tal- punteġġ PASI minn 17 sa 18 u linja bażi medjana tal- Erja tas - Superfiċje tal- Ġisem (BSA) ≥ 20 (u medjan ta ’ l- Indiċi Dermatoloġiċi dwar il- Kwalità tal- Ħajja
Approximately one third (PHOENIX 1) and one quarter (PHOENIX 2) of subjects had Psoriatic Arthritis (PsA).
Bejn wieħed u ieħor terz (PHOENIX 1) u kwart (PHOENIX 2) tal- individwi kellhom Artrite tal- Psorijasi (PsA)..
The primary endpoint in both studies was the proportion of patients who achieved PASI 75 response from baseline at Week 12 (see Table 2).
Il- mira ewlienija fiż- żewġ studji kienet il- proporzjon ta ’ pazjenti li kisbu rispons PASI 75 mill- linja bażi fit- 12- il Ġimgħa (ara Tabella 2).
7 Table 2 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Tabella 2 Sommarju tar- rispons kliniku fl- Istudju tal- Psorijasi 1 (PHOENIX 1) u fl- Istudju tal - Psorijasi 2 (PHOENIX 2)
Week 12 (2 injections)
Ġimgħa 12 (2 injezzjonijiet)
Week 28 (3 injections)
Ġimgħa 28 (3
Psoriasis Study 1
injezzjonijiet)
Number of patients randomised
Numru ta ’ pazjenti randomised
PASI 50 response N (%)
Rispons PASI 26 (10%) 50 N (%)
PASI 75 response N (%)
Rispons PASI 8 (3%) 75 N (%)
PASI 90 response N (%)
Rispons PASI 5 (2%) 90 N (%)
PGAb of cleared or minimal 10 (4%) N (%)
PGAb ta ’
156 (61%) a
10 (4%) psorijasi li fieqet jew hija minima N (%)
Psoriasis Study 2
L- Istudju tal - Psorijasi 2
Number of patients 410 randomised
Numru ta ’ 410 pazjenti randomised
PASI 50 response N (%) 41 (10%)
Rispons PASI 41 (10%) 50 N (%)
PASI 75 response N (%)
Rispons PASI 15 (4%) 75 N (%)
PASI 90 response N (%)
Rispons PASI 3 (1%) 90 N (%)
PGAb of cleared or minimal 18 (4%) N (%) a
PGAb ta ’
p < 0.001 for 45 mg or 90 mg in comparison b PGA = Physician Global Assessment
p < 0. 001 għal 45 mg jew 90 mg meta mqabbel ma ’ plaċebo (PBO). b PGA = (Patient Global Assessment) Stima Globali tat- Tabib Fl- Istudju tal- Psorijasi 1 il- manteniment ta ’ PASI 75 kien sinifikament superjuri b’ kura kontinwa meta mqabbel ma ’ kura li twaqqfet (p < 0. 001).
Similar results were seen with each dose of ustekinumab.
Riżultati jixxiebhu ġew osservati b’ kull doża ta ’ ustekinumab.
At Week 52, 89% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 63% of patients re-randomised to placebo (treatment withdrawal) (p < 0.001).
Fil- Ġimgħa 52, 89% tal- pazjenti randomised mill- ġdid għal kura ta ’ manteniment kienu dawk li kisbu rispons PASI 75 meta mqabbla ma ’ 63% tal- pazjenti li kienu randomised mill- ġdid għall- plaċebo (twaqqif tal- kura) (p < 0. 001).
At week 76, 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
Fil- ġimgħa 76, 84% tal- pazjenti randomised mill- ġdid għall- kura ta ’ manteniment kienu dawk li kisbu rispons ta ’ PASI 75 meta mqabbla ma ’ 19% tal - pazjenti randomised mill- ġdid għall- plaċebo (twaqqif tal- kura).
In patients re-randomised to placebo, and who reinitiated their original ustekinumab treatment regimen after loss of ≥ 50% of PASI improvement 85% regained PASI 75 response within 12 weeks after re-initiating therapy.
Fil- pazjenti randomised mill- ġdid għall- plaċebo u li reġgħu bdew il- kura b’ ustekinumab li kellhom oriġinarjament wara telf ta ’ ≥ 50% ta ’ titjib PASI, 85% reġgħu kisbu rispons PASI 75 fi żmien 12- il ġimgħa wara li reġgħu bdew il- kura.
In Psoriasis Study 1, at Week 2 and Week 12, significantly greater improvements from baseline were demonstrated in the DLQI in each ustekinumab treatment group compared with placebo.
8 Fl- Istudju tal- Psorijasi 1, intwerew titjibiet sinifikament ogħla mill- linja bażi fil- Ġimgħa 2 u fil - Ġimgħa 12 fid- DLQI meta mqabbel ma ’ plaċebo f’ kull wieħed mill- gruppi ta ’ kura b’ ustekinumab.
The improvement was sustained through Week 28.
Dan it- titjib inżamm sal- Ġimgħa 28.
Similarly, significant improvements were seen in Psoriasis Study 2 at Week 4 and 12, which were sustained through Week 24.
Titjibiet sinifikanti jixbhuhom ġew osservati fl- Istudju tal - Psorijasi 2 fil- Ġimgħa 4 u 12, li nżammu sal- Ġimgħa 24.
In Psoriasis Study 1, improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in each ustekinumab treatment group compared with placebo.
Fl- Istudju tal- Psorijasi 1, titjib fil- psorijasi tad- difer (l- Indiċi tal- Qawwa tal- Psorijasi fid- Difer), titjib fil- punteġġi tas- sommarju tal- komponenti fiżiċi u mentali tal- SF- 36 u titjib fl- iSkala Analoga Viżwali (VAS) tal- Ħakk kienu wkoll sinifikanti f’ kull grupp ta ’ kura b’ ustekinumab meta mqabbel ma ’ plaċebo.
In Psoriasis Study 2, the Hospital Anxiety and Depression Scale (HADS) and Work Limitations Questionnaire (WLQ) were also significantly improved in each ustekinumab treatment group compared with placebo.
5. 2 Tagħrif farmakokinetiku
Absorption The median time to reach the maximum serum concentration (tmax) was 8.5 days after a single 90 mg subcutaneous administration in healthy subjects.
Assorbiment Il- medjan tal- ħin biex tintlaħaq l- ogħla konċentrazzjoni fis- serum (tmax) kien ta ’ 8. 5 jum wara li ngħatat doża waħda ta ’ 90 mg taħt il- ġilda f’ individwi b’ saħħithom.
The median tmax values of ustekinumab following a single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to those observed in healthy subjects.
Il- valuri medjani ta ’ tmax ta ’ ustekinumab wara li ngħatat doża waħda ta ’ 45 mg jew 90 mg taħt il- ġilda f’ pazjenti bil- psorijasi kienu kumparabbli ma ’ dawk osservati f’ individwi b’ saħħithom.
The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57.2% in patients with psoriasis.
Il- bijodisponibbiltà assoluta ta ’ ustekinumab wara doża waħda mogħtija taħt il- ġilda ġie stmat li kienet 57. 2% f’ pazjenti bil- psorijasi.
Distribution Median volume of distribution during the terminal phase (Vz) following a single intravenous administration to patients with psoriasis ranged from 57 to 83 ml/ kg.
Distribuzzjoni Il- medjan tal- volum ta ’ distribuzzjoni waqt l- aħħar fażi (Vz) wara doża waħda mogħtija fil- vina lill - pazjenti bil- psorijasi kien f’ medda bejn 57 u 83 ml/ kg.
Metabolism The exact metabolic pathway for ustekinumab is unknown.
Metaboliżmu M’ hijiex magħrufa n- nisġa eżatta ta ’ metaboliżmu ta ’ ustekinumab.
Elimination Median systemic clearance (CL) following a single intravenous administration to patients with psoriasis ranged from 1.99 to 2.34 ml/ day/ kg.
Eliminazzjoni Il- medjan tat- tneħħija sistemika (CL) wara doża waħda mogħtija fil- vina lill- pazjenti bi psorijasi kien f’ medda bejn 1. 99 u 2. 34 ml/ jum/ kg.
Median half-life (t1/ 2) of ustekinumab was approximately 3 weeks in patients with psoriasis, ranging from 15 to 32 days across all psoriasis studies.
Il- medjan tal- half- life (t1/ 2) ta ’ ustekinumab kien bejn wieħed u ieħor ta ’ 3 ġimgħat f’ pazjenti bil- psorijasi, fuq medda minn 15 sa 32 jum fl- istudji kollha tal- psorijasi.
In a population pharmacokinetic analysis, the apparent clearance (CL/ F) and apparent volume of distribution (V/ F) were 0.465 l/ day and 15.7 l, respectively, in patients with psoriasis.
F’ analiżi ta ’ farmakokinetika tal- popolazzjoni, hu maħsub li t- tneħħija (CL/ F) u l- volum ta ’ distribuzzjoni (V/ F) kienu 0. 465 l/ jum and 15. 7 l, rispettivament, f’ pazjenti bil- psorijasi.
The CL/ F of ustekinumab was not impacted by gender.
Is- CL/ F ta ’ ustekinumab kien l- istess fl- irġiel u fin- nisa.
Population pharmacokinetic analysis showed that there was a trend towards a higher clearance of ustekinumab in patients who tested positive for antibodies to ustekinumab.
Analiżi tal- farmakokinetika tal- popolazzjoni wriet li kien hemm tendenza ta ’ tneħħija ogħla ta ’ ustekinumab f’ pazjenti li kellhom riżultat pożittiv għal antikorpi ta ’ ustekinumab
Dose linearity The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose- proportional manner after a single intravenous administration at doses ranging from 0.09 mg/ kg to 4.5 mg/ kg or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis.
Il- kwalità lineari tad- doża L- esponimnet sistemiku ta ’ ustekinumab (Cmax u AUC) żdied bejn wieħed u ieħor b’ mod proporzjonali mad- doża wara li ngħatat doża waħda ġol- vina f’ dożi fuq medda ta ’ bejn 0. 09 mg/ kg u 4. 5 mg/ kg, jew wara li ngħatat doża waħda taħt il- ġilda f’ dożi fuq medda ta ’ bejn wieħed u ieħor 24 mg u 240 mg f’ pazjenti bil- psorijasi.
Single dose vs. multiple doses Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple subcutaneous dose administrations.
Doża waħda vs. ħafna dożi Il- profili tal- ammont ta ’ ustekinumab fis- serum skond il- ħin ġeneralment setgħu jitbassru wara l- għoti ta ’ doża waħda jew ħafna dożi taħt il- ġilda.
Steady-state serum concentrations of ustekinumab were achieved by Week 28 after initial subcutaneous doses at Weeks 0 and 4 followed by doses every 12 weeks.
Konċentrazzjonijiet ta ’ ustekinumab fis- serum fl- istat fiss inkisbu sal- Ġimgħa 28 wara dożi tal- bidu li ngħataw taħt il- ġilda fil- Ġimgħat 0 u 4 segwiti minn dożi kull 12- il- ġimgħa.
The median steady-state trough concentration ranged from 0.21 µg/ ml to 0.26 µg/ ml (45 mg) and from 0.47 µg/ ml to 0.49 µg/ ml (90 mg).
Il- medjan tal- konċentrazzjoni minimali fl- istat fiss kien fuq medda minn 0. 21 µg/ ml sa 0. 26 µg/ ml (45 mg) u minn 0. 47 µg/ ml sa 0. 49 µg/ ml (90 mg).
There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.
Ma deher li kien hemm l- ebda akkumulazzjoni ta ’ konċentrazzjonijiet ta ’ ustekinumab fis- serum fuq perijodu ta ’ żmien meta ngħata taħt il- ġilda kull 12- il ġimgħa.
Impact of weight on pharmacokinetics In a population pharmacokinetic analysis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
L- impatt tal- piż fuq il- farmakokinetika F’ analiżi tal- farmakokinetika tal- popolazzjoni, instab li l- piż tal- ġisem kien l- aktar parametru sinifikanti li qed jaffettwa t- tneħħija ta ’ ustekinumab.
The median CL/ F in patients with weight > 100 kg was approximately 55% higher compared to patients with weight ≤ 100 kg.
Il- medjan ta ’ CL/ F f’ pazjenti b’ piż > 100 kg
The median V/ F in patients with weight > 100 kg was approximately 37% higher as compared to patients with weight ≤ 100 kg.
Il- medjan ta ’ V/ F f’ pazjenti b’ piż > 100 kg kien bejn wieħed u ieħor 37% ogħla meta mqabbel ma ’ pazjenti b’ piż ta ’ ≤ 100 kg.
The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Il- medjan tal- konċentrazzjonijiet minimi ta ’ ustekinumab fis- serum f’ pazjenti b’ piż akbar (> 100 kg) fil- grupp ta ’ 90 mg kien jixbah dak f’ pazjenti b’ piż anqas (≤ 100 kg) fil- grupp ta ’ 45 mg.
Special populations No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Popolazzjonijiet speċjali L- ebda tagħrif farmakokinetiku ma huwa disponibbli f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi jew tal- fwied.
No specific studies have been conducted in elderly patients.
L- ebda studji speċifiċi ma saru f’ pazjenti anzjani.
In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or alcohol on the pharmacokinetics of ustekinumab.
Fl- analiżi tal- farmakokinetika tal- popolazzjoni, ma kien hemm l- ebda indikazzjonijiet ta ’ effett tat - tabakk jew l- alkoħol fuq il- farmakokinetika ta ’ ustekinumab.
Non-clinical data reveal no special hazard (e. g. organ toxicity) for humans based on studies of repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology evaluations.
Informazzjoni mhux klinika inkluż evalwazzjonijiet ta ’ sigurtà farmakoloġika bbażata fuq studji ta ’ effett tossiku minn dożi ripetuti u effett tossiku fuq l- iżvilupp u s- sistema riproduttiva, ma turi l- ebda periklu speċjali (eż. tossiċità ta ’ l- organi) fil- bniedem.
In developmental and reproductive toxicity studies in cynomolgus monkeys, neither adverse effects on male fertility indices nor birth defects or developmental toxicity were observed.
Fl- istudji ta ’ l- effett tossiku fuq l- iżvilupp u s - sistema riproduttiva fix- xadini cynomolgus ma kienu osservati la effetti avversi fuq l- indiċi tal- fertilità fl- irġiel u lanqas difetti serji tat- twelid jew effetti tossiċi fuq l- iżvilupp.
No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/ 23 in mice.
L- ebda effetti avversi fuq l - indiċi tal- fertilità fin- nisa ma kienu osservati bl- użu ta ’ antikorpi analogi għall- IL- 12/ 23 fil- ġrieden.
Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in monkeys that were more than 100-fold higher than observed in humans.
Livelli tad- doża fl- istudji fuq l- annimali kienu bejn wieħed u ieħor sa 45 darba ogħla mill- ogħla doża ekwivalenti għal dik intenzjonata li tingħata lill- pazjenti bil- psorijasi u wasslet għall- ogħla konċentrazzjonijiet tas- serum fix- xadini li kienu aktar minn 100 darba ogħla min dawk osservati fil - bnedmin.
Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models for an antibody with no cross-reactivity to rodent IL-12/ 23 p40.
Ma sarux studji ta ’ karċinoġeniċità b’ ustekinumab minħabba n- nuqqas ta ’ mudelli xierqa għal antikorp li ma kellux cross- reactivity għall- IL- 12/ 23 p40 ta ’ l- annimali gerriema.
Sucrose L-histidine L-histidine monohydrochloride monohydrate Polysorbate 80 Water for injections
Sucrose L- histidine L- histidine monohydrochloride monohydrate Polysorbate 80 Ilma għall- injezzjonijiet
12 months
12- il xahar
Store in a refrigerator (2ºC - 8ºC).
Aħżen fi friġġ (2ºC - 8ºC).
STELARA is supplied as a sterile solution in a single-use type I glass 2 ml vial closed with a coated butyl rubber stopper.
10 STELARA huwa fornut bħala soluzzjoni sterili f’ fjala li jintuża darba biss ta ’ 2 ml tal- ħġieġ tat- tip I magħluq b’ tapp tal- lastku butyl miksi.
STELARA is available in a 1 vial pack.
STELARA huwa disponibbli f’ pakkett b’ fjala wieħed.
The solution in the STELARA vial should not be shaken.
Is- soluzzjoni fil- fjala ta ’ STELARA m’ għandhiex titħawwad.
The solution should be visually inspected for particulate matter or discoloration prior to subcutaneous administration.
Is- soluzzjoni għandha tiġi miflija għal frak jew telf ta ’ kulur qabel ma tingħata taħt il- ġilda.
The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein.
Is- soluzzjoni hija minn ċara sa ftit tkanġi, minn trasparenti sa safra ċara u jista ’ jkun fiha xi ftit frak tasluċidu jew abjad tal- proteina.
This appearance is not unusual for proteinaceous solutions.
Din id- dehra m’ hijiex ħaġa mhux tas- soltu f’ soluzzjonijiet tal- proteina.
The product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Il- prodott m’ għandux jintuża jekk is - soluzzjoni titlef il- kulur jew tiddardar, jew jekk ikun fiha xi frak mhux floku.
Before administration, STELARA should be allowed to reach a comfortable temparature for injection (approximately half an hour).
Qabel ma jingħata STELARA għandu jitħalla jilħaq temperatura komda għall- injezzjoni (bejn wieħed u ieħor madwar nofs siegħa).
10 remaining in the vial and the syringe should not be used.
STELARA ma fihx preservattivi; għalhekk kull fdal li jibqa ’ fil- fjala u fis- siringa m’ għandux jintuża.
Detailed instructions for use are provided in the package leaflet.
Istruzzjonijiet iddettaljati dwar l- użu huma pprovduti fil- fuljett ta ’ tagħrif.
Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse Il- Belġju
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni ddettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
STELARA 90 mg solution for injection
STELARA 90 mg soluzzjoni għall- injezzjoni
Each vial contains 90 mg ustekinumab in 1 ml.
Kull fjala fih 90 mg ustekinumab f’ 1. 0 ml.
12 Renal and hepatic impairment STELARA has not been studied in these patient populations.
Indebolimet tal- kliewi u tal- fwied STELARA ma ġiex studjat f’ dawn il- popolazzjonijiet ta ’ pazjenti.
Method of administration STELARA is for subcutaneous injection.
12 Kif jingħata STELARA għandu jingħata b’ injezzjoni taħt il- ġilda.
Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section 4.8).
Fi studji kliniċi, xi pazjenti li ngħataw STELARA żviluppaw tumuri malinni tal- ġilda u oħrajn mhux tal- ġilda (see section 4. 8).
13 Vaccinations It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
13 rċievew tilqim virali ħaj jew batterjali ħaj.
14 Lactation It is unknown whether ustekinumab is excreted in human breast milk.
Treddigħ M’ huwiex magħruf jekk ustekinumab joħroġx mal- ħalib tas- sider tal- omm.
4.8 Undesirable effects
4. 9 Effetti mhux mixtieqa
15 Infections In controlled studies of psoriasis patients, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
15 Infezzjonijiet Fi studji kkontrollati ta ’ pazjenti bil- psorijasi, ir- rati ta ’ infezzjonijiet jew infezzjonijiet serji kienu jixtiebhu bejn pazjenti kkurati b’ ustekinumab u dawk ikkurati bi plaċebo.
In the controlled and non-controlled portions of psoriasis clinical studies, the incidence of malignancies excluding non-melanoma skin cancers was 0.36 per 100 patient-years of follow-up for ustekinumab-treated patients (8 patients in 2,249 patient-years of follow-up) and malignancies reported included breast, colon, head and neck, kidney, prostate, and thyroid cancers.
Fil- partijiet ta ’ l- istudji kliniċi tal- psorijasi kkontrollati u mhux ikkontrollati, l- inċidenza ta ’ tumuri malinni minbarra l- kankri tal- ġilda li m’ humiex melanoma kienet ta ’ 0. 36 għal kull 100 sena ta ’ sorveljanza wara l- kura ta ’ pazjent għal pazjenti kkurati b’ ustekinumab (8 pazjenti f’ 2, 249 sena ta ’ sorveljanza wara l- kura ta ’ pazjent) u tumuri malinni rrapportati kienu jinkludu kankri tas- sider, tal - musrana l- kbira, tar- ras, ta ’ l- għonq, tal- kliewi, tal- prostata u tat- tirojde.
Single doses up to 4.5 mg/ kg have been administered intravenously in clinical studies without dose-limiting toxicity.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat.
16 5.
16 Dożi waħdiet sa 4. 5 mg/ kg ingħataw ġol- vina fi studji kliniċi mingħajr tossiċità li tillimita d- doża.
17 Table 2 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Tabella 2 Sommarju tar- rispons kliniku fl- Istudju tal- Psorijasi 1 (PHOENIX 1) u fl- Istudju tal - Psorijasi 2 (PHOENIX 2)
In Psoriasis Study 1, at Week 2 and Week 12, significantly greater improvements from baseline were demonstrated in the DLQI in each ustekinumab treatment group compared with placebo.
18 Fl- Istudju tal- Psorijasi 1, intwerew titjibiet sinifikament ogħla mill- linja bażi fil- Ġimgħa 2 u fil - Ġimgħa 12 fid- DLQI meta mqabbel ma ’ plaċebo f’ kull wieħed mill- gruppi ta ’ kura b’ ustekinumab.
STELARA is supplied as a sterile solution in a single-use type I glass 2 ml vial closed with a coated butyl rubber stopper.
20 STELARA huwa fornut bħala soluzzjoni sterili f’ fjala li jintuża darba biss ta ’ 2 ml tal- ħġieġ tat- tip I magħluq b’ tapp tal- lastku butyl miksi.
The solution in the STELARA vial should not be shaken.
Is- soluzzjoni fil- kunjett ta ’ STELARA m’ għandhiex titħawwad.
20 remaining in the vial and the syringe should not be used.
STELARA ma fihx preservattivi; għalhekk kull fdal li jibqa ’ fil- kunjett u fis- siringa m’ għandux jintuża.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Manufacturer of the active substance
Manifattur tas- sustanza bijoloġika attiva
Louis, MO 63134 USA
Louis, MO 63134 Stati Uniti
Centocor BV Einsteinweg 101 NL-2333 CB Leiden The Netherlands
Centocor BV Einsteinweg 101 NL- 2333 CB Leiden L- Olanda
Summary of Product Characteristics, Section 4.2).
Sommarju tal - Karatteristiċi tal - Prodott, sezzjoni 4. 2).
The Marketing authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Stelara are provided with educational materials containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li, meta l- prodott ikun fis- suq, il- professjonisti tas- saħħa li għandhom esperjenza jippreskrivu/ jużaw Stelara jingħataw materjal edukattiv li fih dan li ġej:
The objectives of this Health Care Professional educational program will be focused on: • Local Guidance for TB screening (see draft materials in RMP Appendix 1). • The potential risks will be the focus of this EM
L- iskop ta ’ dan il- programm edukattiv għall- professjonisti tas- saħħa jkun iffukat fuq: • Gwida lokali għall- monitoraġġ ta ’ TB (ara l- abbozz tal- materjali fl- RMP appendiċi 1). • Ir- rikji potenzjali jkunu l- fokus ta ’ dan il- materjal edukattiv
- Serious infections including salmonella, TB, and non-tuberculous mycobacterial infections-
- Infezzjonijiet serji li jinkludu salmonella, TB, u infezzjonijiet ta ’ mycobacterium li
- Malignancies
- Tumuri malinni
Patient information pack will be focused on: • Potential risks/ side effects as described in the Patient Information Sheet. • Serious infections, including salmonella infections, TB, and non-tuberculous mycobacterial infections. • Malignancies
Il- pakkett ta ’ informazzjoni għall- pazzjenti jkun iffukat fuq: • Riskji/ effetti mhux mixtieqa potenzjali kif deskritt fil- fuljett ta ’ tagħrif • Infezzjonijiet serji li jinkudu salmonella, TB, u infezzjonijiet ta ’ mycobacterium li mhumiex tuberkulużi • Tumuri malinni
• Appropriate techniques for administration of ustekinumab.
• Metodi xierqa ta ’ kif għandu jingħata ustekinumab.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 002 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni 002 ippreżentata f’ Module 1. 8. 1 tal- Applikazzjoni tal -
23 Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.6 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
23 Awtorizzazzjoni għat- tqegħid fis- Suq, qegħda fis- seħħ u tiffunzjona qabel u waqt li l- prodott ikun fis - suq.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- linji gwida tas- CHMP fuq sistemi dwar l- immaniġġar tar- riskji għall- prodotti mediċinali għall- użu fil- bniedem, il- pjan ta ’ l- immaniġġar tar- riskju aġġornat għandu jiġi sottomess fl- istess ħin ta ’ l- PSUR li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Fi żmien 60 ġurnata minn meta tintlaħaq ġrajja importanti (ta ’ farmakoviġilanza jew minimizzazzjoni tar- riskji)
24 ANNEX III
24 ANNESS III
VIAL CARTON TEXT (45 mg)
TEST TAL- KARTUNA TAL- FJALA (45 mg)
STELARA 45 mg solution for injection ustekinumab
STELARA 45 mg soluzzjoni għall- injezzjoni ustekinumab
Each vial contains 45 mg of ustekinumab in 0.5 ml.
Kull fjala fih 45 mg ta ’ ustekinumab f’ 0. 5 ml.
Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Sucrose, L- histidine, L- histidine monohydrochloride monohydrate, polysorbate 80, ilma għall- injezzjonijiet.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection 45 mg/ 0.5 ml 1 vial
GĦAMLA FARMAĊEWTIKA U KONTENUT Soluzzjoni għall- injezzjoni 45 mg/ 0. 5 ml Fjala 1
METHOD AND ROUTE(S) OF ADMINISTRATION Do not shake.
MOD TA ’ KIF U MNEJN JINGĦATA Tħawwdux.
VIAL LABEL TEXT (45 mg)
TEST TAT- TIKKETTA TAL- FJALA (45 mg)
STELARA 45 mg solution for injection ustekinumab SC
STELARA 45 mg soluzzjoni għall- injezzjoni ustekinumab SC
45 mg/ 0.5 ml
45 mg/ 0. 5 ml
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
VIAL CARTON TEXT (90 mg)
TEST TAL- KARTUNA TAL- FJALA VIAL (90 mg)
STELARA 90 mg solution for injection ustekinumab
STELARA 90 mg soluzzjoni għall- injezzjoni ustekinumab
Each vial contains 90 mg of ustekinumab in 1 ml.
Kull fjala fih 90 mg ta ’ ustekinumab f’ 1 ml.
Solution for injection 90 mg/ 1 ml 1 vial
Soluzzjoni għall- injezzjoni 90 mg/ 1 ml Fjala 1
Do not shake.
Tħawwdux.
30 11.
30 Tagħmlux fil- friża.
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL LABEL TEXT (90 mg)
TEST TAT- TIKKETTA TAL- FJALA (90 mg)
STELARA 90 mg solution for injection ustekinumab SC
STELARA 90 mg soluzzjoni għall- injezzjoni ustekinumab SC
33 PACKAGE LEAFLET:
33 FULJETT TA ’ TAGĦRIF:
STELARA 45 mg solution for injection Ustekinumab
STELARA 45 mg soluzzjoni għall- injezzjoni Ustekinumab
What STELARA is and what it is used for 2.
X’ inhu STELARA u għalxiex jintuża 2.
Before you use STELARA 3.
Qabel ma tuża STELARA 3.
How to use STELARA 4.
Kif għandek tuża STELARA 4.
How to store STELARA 6.
Kif taħżen STELARA 6.
WHAT STELARA IS AND WHAT IT IS USED FOR
X’ INHU STELARA U GĦALXIEX JINTUŻA
STELARA belongs to a group of medicines called immunosuppressants (medicines that inhibit your immune system).
STELARA huwa wieħed minn grupp ta ’ mediċini msejħa immunosoppressanti (mediċini li jimpedixxu s- sistema immuni tiegħek).
STELARA contains the active substance ustekinumab, a monoclonal antibody.
STELARA fih is- sustanza attiva ustekinumab li huwa antikorp monoklonali.
STELARA is used to treat moderate to severe plaque psoriasis in patients who cannot use or did not respond to other medicines and phototherapy.
STELARA jintuża biex jikkura psorijasi bil- qoxra minn moderata sa qawwija f’ pazjenti li ma jistgħux jużaw jew ma marrux tajjeb b’ mediċini oħra u fototerapija.
This disease causes inflammation of skin and nails.
Din il- marda tikkawża infjammazzjoni tal - ġilda u d- dwiefer.
STELARA will reduce the inflammation and other signs of the disease.
STELARA se jnaqqas l- infjammazzjoni u sinjali oħra tal- marda.
BEFORE YOU USE STELARA
QABEL MA TUŻA STELARA