FrancophonIA/ELRC3.0 huggingface dataset:
English: * Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Maltese: * Magħmul minn ċelluli tal-ovarju tal-ħamster Ċiniż (CHO) bit-teknoloġija rikombinanti tad-DNA.
English: Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, Osigraft should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus (see sections 4.4 and 5.3).
Maltese: .3) Minħabba r-riskji mhux magħrufa għall-fetu assoċjati mal-iżvilupp potenzjali tal-anti-korpi newtralizzanti għall-protein OP-1, Osigraft m'għandux jintuża matul it-tqala għajr meta l-benefiċċju potenzjali jiġġustifika r-riskji potenzjali għall-fetu (ara sezzjonijiet 4.4 u 5.3).
English: Method of administration: Intraosseous use.
Maltese: Għall-użu intrajossew.
English: - when there are any tumours in the area of the non-union site.
Maltese: - meta jkun hemm kwalunkwe tumuri fiż-żona tas-sit 'non-unjoni.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: Sterile sodium chloride solution for injection and contents of the Osigraft vial are transferred to a sterile bowl and mixed with a sterile spatula or curette.
Maltese: Applika l-prodott rikostitwit fis-sit ippreparat osseu permezz ta' strument sterili bħal ngħidu aħna spatula jew kurette.
English: This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it. Osigraft is implanted in adult patients with fractures of the tibia which have failed to heal for at least 9 month duration in cases where treatment with autograft (transplanted bone from your hip) has failed or should not be used.
Maltese: - jekk it-tabib tiegħek jiddeċiedi li għandek kopertura inadekwata tal-ġilda (fis-sit tal-frattura) u kwantità mhux adekwata tad-demm fis-sit tal-intervent kirurġiku tiegħek.. - għal ksur (fix-xewka) vertebrali. - għat-trattament non-unjoni minħabba fratturi patoloġikali (li għandhom x'jaqsmu mal-mard),
English: Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before undergoing treatment with Osigraft.
Maltese: Nisa li jista' jkollhom it-tfal għandhom jinformaw lill-kirurgu tagħhom dwar il-possibilità ta' tqala qabel it-trattament b'din il-mediċina.
English: Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Maltese: IgG u anti-OP-1 filħalib matul il-fażi ta' l-istudju kollu ta' wara t-twelid sat-28 ġurnata tat-treddigħ (ara sezzjoni 4.6).
English: The Marketing Authorisation Holder will continue to submit PSURs every three years.
Maltese: Il-potenzjal ta' ħsara għat-tarbija mredda' mhuwiex magħruf.
English: Antibodies were detectable in adults and offspring during the gestation and lactation periods.
Maltese: L-anti-korpi kienu osservati f'adulti u trabi matul il-perijodu tal-ġestazzjoni u tattreddigħ.
English: The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended (see section 4.5).
Maltese: L-użu ta' Osigraft b'filler sintetiku biex jimla l-ispazju bejn l-għadam għandu mnejn jirriżulta f'riskju ta' żieda fl-infjamazzjoni lokali, infezzjoni lokali u xi kultant migrazzjoni tal-materjal impjantat u għalhekk mhux irrakkomandat(ara sezzjoni 4.5).
English: Single dose and repeat dose studies in a range of animal models (rats, dogs and primates) were performed.
Maltese: Saru studji ta' doża waħda u dawk ripetuti fuq firxa ta' modelli ta' annimali (firien, klieb u primati).
English: When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.
Maltese: Meta jkun rikonstitwit, Osigraft għandu l-konsistenza ta' ramel imxarrab, li jiffaċilita l-impjantazzjoni u tpoġġija fis-sit tad-difetti ta' l-għadma.
English: The following table of adverse reactions was compiled from those observed and recorded during clinical trials.
Maltese: It-tabella li ġejja dwar reazzjonijiet avversi ġiet miġbura minn fost dawk osservati u rreġistrati waqt il-provi kliniċi.
English: Once bound at the cell surface, the active substance induces a cascade of cellular events leading to the formation of chondroblasts and osteoblasts, which play a key role in the bone formation process.
Maltese: , Ma kienet osservata l-ebda assoċjazzjoni mar-riżultat klinikali jew episodju avvers fi studji klinikali.
English: Common
Maltese: BŻONN
English: Animal studies were conducted that cannot rule out effects of anti-OP-1 antibodies on embryo-foetal development (see section 5.3).
Maltese: Studji li saru fuq bhejjem m'humiex biżżejjed rigward l-effetti ta' antikorpi ta' antiOP-1 fuq l-iżvilupp embriju/fetu (ara sezzjoni 5
English: - if you have active infection at the site of non-union (inflammation and drainage at the site of
Maltese: - jekk għandek infezzjoni attiva fis-sit non-unjoni (infjammazzjoni u tnixxija fis-sit tal-korriment)
English: The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
Maltese: L-istudju pivotali Nonunjoni Tibjali ipparaguna Osigraft ma' l-awtotrapjant, bl-aħħar stadju ta' proċess primarju ta' effikaċja 9 xhur wara t-trattament.
English: Regulation of CYP450 enzymes
Maltese: Regolazzjoni tal-enzimi CYP450
English: Uncommon: Depression
Maltese: Mhux komuni: Depressjoni
English: • Itching (‘pruritus')
Maltese: • Ħakk (‘pruritus')
English: Date of first authorisation: 16 January 2009 Date of latest renewal: 19 September 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Jannar 2009 Data tal-aħħar tiġdid: 19 ta' Settembru 2013
English: UNIFI-I included 961 patients.
Maltese: UNIFI-I kien jinkludi 961 pazjent.
English: Adolescent patients (12-17 years)
Maltese: Pazjenti adolexxenti (12-17-il sena)
English: Endoscopic Normalization
Maltese: Normalizzazzjoni endoskopika
English: • The active substance is ustekinumab.
Maltese: • Is-sustanza attiva hi ustekinumab.
English: * See section 4.4, Systemic and respiratory hypersensitivity reactions.
Maltese: * Ara sezzjoni 4.4, Reazzjonijiet sistemiċi u respiratorji ta' sensittività eċċessiva.
English: The induction studies included 1409 (UNITI-1, n = 769; UNITI-2 n = 640) patients.
Maltese: L-istudji ta' induzzjoni kienu jinkludu 1409 (UNITI-1, n = 769; UNITI-2 n = 640) pazjenti.
English: > 55 kg to ≤ 85 kg
Maltese: > 55 kg sa ≤ 85 kg
English: Placebo N = 247
Maltese: Plaċebo N = 247
English: Clinically important, active infection (e.g. active tuberculosis; see section 4.4).
Maltese: Infezzjoni attiva klinikament sinifikanti (eż. tuberkulosi attiva, ara sezzjoni 4.4).
English: The syringe is fitted with a passive safety guard.
Maltese: Is-siringa fiha protezzjoni ta' sigurtà passiva.
English: Traceability:
Maltese: Traċċabilità:
English: Endoscopy
Maltese: Endoskopija
English: 3 years.
Maltese: 10 sekondi.
English: Placebo N = 209
Maltese: Plaċebo N = 209
English: A TNFα antagonist and/or vedolizumab.
Maltese: Antagonist ta' TNFα u/jew vedolizumab.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C.
Maltese: Stabbiltà kimika u fiżika waqt l-użu ntweriet għal 8 sigħat f'temperatura ta' 15-25°C.
English: Patients enrolled PGA
Maltese: Pazjenti rreġistrati PGA
English: Table 2 List of adverse reactions System Organ Class
Maltese: Tabella 2 Lista tar-reazzjonijiet avversi Sistema tal-Klassifika talOrgani
English: Table 3 List of adverse reactions System Organ Class
Maltese: Tabella 3 Lista tar-reazzjonijiet avversi Sistema tal-Klassifika talOrgani
English: Johnson & Johnson d.o.o.
Maltese: Johnson & Johnson d.o.o. Tel.
English: Stelara contains sodium
Maltese: Stelara fih sodium
English: Stelara can cause serious side effects, including allergic reactions and infections.
Maltese: Stelara jista' jikkawża effetti sekondarji serji, inklużi reazzjonijiet allerġiċi u infezzjonijiet.
English: In PsA Study 1 (PSUMMIT I) and PsA Study 2 (PSUMMIT II), 80% and 86% of the patients, respectively, had been previously treated with DMARDs.
Maltese: F'PsA Study 1 (PSUMMIT I) u PsA Study 2 (PSUMMIT II), 80% u 86% tal-pazjenti, rispettivament, kienu ġew ikkurati fil-passat b'DMARDs.
English: Stelara belongs to a group of medicines called ‘immunosuppressants'.
Maltese: Stelara huwa wieħed minn grupp ta' mediċini msejħa ‘immunosoppressanti'.
English: Clinical Remission*
Maltese: Remissjoni Klinika*
English: For the placebo group at week 12, N = 36 p = 0.028
Maltese: Għall-grupp ta' plaċebo f'Ġimgħa 12, N = 36 p = 0.028
English: Etanercept 24 doses (50 mg twice a week)
Maltese: Etanercept 24 doża (50 mg darbtejn filġimgħa)
English: Manufacturer Janssen Biologics B.V. Einsteinweg 101
Maltese: Manifattur Janssen Biologics B.V. Einsteinweg 101
English: Elderly (≥ 65 years)
Maltese: Anzjani (≥ 65 snin)
English: Volume of injection (mL)
Maltese: Volum tal-injezzjoni (mL)
English: Table 3: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Maltese: Tabella 3: Induzzjoni ta' Rispons u Remissjoni Kliniċi f'UNITI-1 u UNITI 2 UNITI-1*
English: PsARC responses were maintained through weeks 52 and 100.
Maltese: Risponsi PsARC inżammu sal-Ġimgħat 52 u 100.
English: Patients with each subtype of PsA were enrolled, including polyarticular arthritis with no evidence of rheumatoid nodules (39%), spondylitis with peripheral arthritis (28%), asymmetric peripheral arthritis (21%), distal interphalangeal involvement (12%) and arthritis mutilans (0.5%).
Maltese: Pazjenti b'kull sottotip ta' PsA ġew irreġistrati, li tinkludi artrite poliartikulari bla ebda evidenza ta' noduli rewmatojde (39%), spondilite b'artrite periferali (28%), artrite periferali asimmetrika (21%), involviment distali bejn is-swaba (12%) u artrite mutilans (0.5%).
English: In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
Maltese: Flanaliżijiet tal-farmakokinetika ta' popolazzjoni fl-istudji tal-fażi 3, kien studjat l-effett ta' prodotti mediċinali konkomitanti użati l-aktar frekwenti f'pazjenti bil-psorijasi (inkluż paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) fuq il-farmakokinetika ta' ustekinumab.
English: Psoriatic arthritis (PsA) (Adults)
Maltese: Artrite psorijatika (PsA) (Adulti)
English: • After the expiry date which is stated on the label and the carton after ‘EXP'.
Maltese: • Wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara ‘EXP'.
English: Ustekinumab 2 doses (week 0 and week 4) 45 mg
Maltese: 2 dożi (Ġimgħa 0 u Ġimgħa 4) 45 mg
English: Concomitant immunosuppressive therapy
Maltese: Kura immunosoppressiva konkomitanti
English: Week 28 3 doses (week 0, week 4 and week 16) PBO 45 mg 90 mg 45 mg 90 mg
Maltese: Ġimgħa 28 3 dożi (Ġimgħa 0, Ġimgħa 4 u Ġimgħa 16) PBO 45 mg 90 mg 45 mg
English: CDLQI of 0 or 1
Maltese: CDLQI ta' 0 jew 1
English: Common: Oropharyngeal pain Uncommon: Nasal congestion Rare: Allergic alveolitis, eosinophilic pneumonia Very rare: Organising pneumonia*
Maltese: Alveolite allerġika, pulmonite eosinofilika Rari ħafna: Pulmonite sistematizzata*
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Maltese: Artrite psorjatika hi marda infjammatorja tal-ġogi, li normalment tkun akkumpanjata minn psorijasi.
English: 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.
Maltese: 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.
English: Psoriatic arthritis (PsA)
Maltese: Artrite psorjatika (PsA)
English: Table 4 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Maltese: Tabella 4 Sommarju tar-rispons kliniku fl-Istudju tal-Psorijasi 1 (PHOENIX 1) u fl-Istudju talPsorijasi 2 (PHOENIX 2)
English: • The recommended starting dose is 45 mg Stelara.
Maltese: • Id-doża rrakkomandata tal-bidu hija ta' 45 mg Stelara.
English: Table 6 Number of patients who achieved clinical response in Psoriatic arthritis Study 1 (PSUMMIT I) and Study 2 (PSUMMIT II) at week 24
Maltese: Tabella 6 Numru ta' pazjenti li kisbu rispons kliniku f'Artrite psorjatika Studju 1 (PSUMMIT I) u Artrite psorjatika Studju 2 (PSUMMIT II) f'Ġimgħa 24
English: Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline
Maltese: Numru ta' pazjenti b'≥ 3% BSA psorijasi b'involviment tal-ġilda fil-linja bażi
English: In patients who failed conventional therapy, but not a biologic c77% (78/102)
Maltese: F'pazjenti li fallew terapija konvenzjonali, iżda mhux sustanza bijoloġika c77% (78/102)
English: PGA of cleared (0) or minimal (1)
Maltese: PGA li fieqet (0) jew hija minima (1)
English: 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).
Maltese: 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).
English: • Psoriatic arthritis - in adults
Maltese: • Artrite psorjatika - fl-adulti
English: Nominally significant (p < 0.05)
Maltese: nominalment sinifikanti (p < 0.05)
English: Maintenance of clinical remission through Week 44 is defined as patients in clinical remission through Week 44 among patients in clinical remission at maintenance baseline.
Maltese: Manteniment ta' remissjoni klinika sa Ġimgħa 44 huwa ddefinit f'pazjenti f'remissjoni klinika sa Ġimgħa 44 fost pazjenti f'remissjoni klinika fil-linja bażi ta' manteniment.
English: The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section 4.5).
Maltese: L-effetti ta' IL-12 jew IL-23 fuq ir-regolazzjoni tal-enzimi CYP450 kien evalwat fi studju in vitro permezz ta' epatoċiti mill-bniedem, li wera li IL-12 u/jew IL-23 f'livelli ta' 10 ng/ml ma biddlux lattivitajiet tal-enzima tal-bniedem CYP450 (CYP1A2, 2B6, 2C9, 2C19, 2D6, jew 3A4; ara sezzjoni 4.5).
English: Table 11: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Maltese: Tabella 11: Sommarju tar-Riżultati l-Aktar Importanti ta' Effikaċja f'UNIFI-I (Ġimgħa 8) Plaċebo
English: Stelara contains the active substance ‘ustekinumab', a monoclonal antibody.
Maltese: Stelara fih is-sustanza attiva ‘ustekinumab' li huwa antikorp monoklonali.
English: Nominally significant (p < 0.001)
Maltese: Sinifikanti b'mod nominali (p<0.001)
English: The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2.
Maltese: L-istudju ta' manteniment (IM-UNITI), evalwa 388 pazjent li kisbu rispons kliniku ta' 100 punt f'ġimgħa 8 ta' induzzjoni b'ustekinumab fl-istudji UNITI-1 u UNITI-2.
English: Ustekinumab demonstrated a statistically significant decrease in the rate of progression of structural damage compared to placebo, as measured by change from baseline to week 24 in the total modified vdH-S score (mean ± SD score was 0.97 ± 3.85 in the placebo group compared with 0.40 ± 2.11 and 0.39 ± 2.40 in the ustekinumab 45 mg (p < 0.05) and 90 mg (p < 0.001) groups, respectively).
Maltese: Ustekinumab wera tnaqqis statistikament sinifikanti fir-rata ta' progressjoni ta' ħsara strutturali meta mqabbel mal-plaċebo, kif tkejjel mill-bidla mil-linja bażi sal-Ġimgħa 24 fil-punteġġ totali mmodifikat vdH-S (medja ± punteġġ SD kien 0.97 ± 3.85 fil-grupp ta' plaċebo meta mqabbel ma' 0.40 ± 2.11 u 0.39 ± 2.40 fil-gruppi ta' ustekinumab ta' 45 mg (p < 0.05) u 90 mg (p < 0.001), rispettivament).
English: Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23.
Maltese: IgG1κ kollu kemm hu uman li jeħel bi speċifiċità massottoparti tal-proteina kondiviża p40 ta' interleukin cytokines umani (IL)-12 u IL-23.
English: UNIFI-M, evaluated 523 patients who achieved clinical response with single IV administration of ustekinumab in UNIFI-I.
Maltese: UNIFI-M, evalwa 523 pazjent li kisbu rispons kliniku b'għoti ta' darba ta' ustekinumab IV f'UNIFI-I.
English: Loss of response was defined as a CDAI score ≥ 220 points and a ≥ 100 point increase from the CDAI score at baseline.
Maltese: Telf ta' rispons kien definit bħala punteġġ ta' CDAI ta' ≥ 220 punt u żieda ta' ≥ 100 punt mill-punteġġ ta' CDAI fillinja bażi.
English: • If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
Maltese: • Jekk inti tiżen bejn 60 kg u 100 kg, id-doża rrakkomandata hija 45 mg Stelara.
English: Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Maltese: Kull kunjett fih 130 mg ustekinumab f'26 mL (5 mg/mL).
English: Recommended dose of ustekinumab N = 249
Maltese: Doża rakkomandata ta' ustekinumab N = 249
English: Table 7 Summary of primary and secondary endpoints at week 12 and week 52 Paediatric psoriasis study (CADMUS) (Age 12-17) Week 12
Maltese: Sommarju tal-iskopijiet finali primarji u sekondarji f'Ġimgħa 12 u Ġimgħa 52 Studju tal-psorijasi pedjatrika (CADMUS) (Età 12-17 il sena) Ġimgħa 12
English: (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials-discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- discard 104 mL)
Maltese: (Armi 26 mL ta' sodium chloride għal kull kunjett ta' STELARA meħtieġ, għal 2 kunjetti armi 52 mL, għal 3 kunjetti armi 78 mL, għal 4 kunjetti armi 104 mL)
English: Gently mix.
Maltese: Tħawwadx.
English: Table 8 Summary of primary and secondary endpoints at week 12 and week 52 Paediatric psoriasis study (CADMUS Jr.) (Age 6-11) Week 12
Maltese: Tabella 8 Sommarju tal-iskopijiet primarji u sekondarji f'ġimgħa 12 u ġimgħa 52 Studju ta' Psorijasi f'pazjenti pedjatriċi (CADMUS Jr.) (Età 6 snin-11-il sena) Ġimgħa 12
English: Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.
Maltese: Immunosoppressanti bħal ustekinumab jistgħu iżidu r-riskju ta' tumuri malinni.
English: Paediatric plaque psoriasis (6 years and older)
Maltese: Psorijasi tal-plakka pedjatrika (6 snin u aktar)
English: Clinical Remission** In patients who failed conventional therapy, but not a biologic d49% (50/102)
Maltese: Remissjoni Klinika** F'pazjenti li fallew terapija konvenzjonali, iżda mhux sustanza bijoloġika d49% (50/102)
English: Efficacy results presented for UNIFI-I and UNIFI-M were based on central review of endoscopies.
Maltese: Ir-riżultati ta' effikaċja għal UNIFI-I u UNIFI-M kienu bbażati fuq reviżjoni ċentrali tal-endoskopiji.
English: Plaque psoriasis (Adults)
Maltese: Psorijasi tal-plakka (Adulti)
English: (see section 5.1, Table 4)
Maltese: .1, Tabella 4).
English: Significant differences in partial Mayo score and symptomatic remission were observed between ustekinumab and placebo as early as Week 2.
Maltese: Ġew osservati differenzi sinifikanti fil-punteġġ parzjali Mayo u remissjoni tas-sintomi bejn ustekinumab u plaċebo sa minn Ġimgħa 2.
English: PASI 75 response N (%)
Maltese: Rispons PASI 75, N (%)
English: Psoriasis or Psoriatic Arthritis
Maltese: Psorijasi jew Artrite Psorijatika
English: • Plaque psoriasis - in adults and children aged 6 years and older
Maltese: • Psorijasi tal-plakka - fl-adulti u fit-tfal b'età ta' 6 snin u aktar
English: In patients who failed conventional therapy, but not a biologic
Maltese: F'pazjenti li fallew terapija konvenzjonali, iżda mhux sustanza bijoloġika
English: Recommende d dose of ustekinumab N = 209
Maltese: Doża rakkomandata ta' ustekinumab N = 209
English: See ‘Serious side effects' in section 4 for a full list of these side effects.
Maltese: Ara ‘Effetti sekondarji serji' fit-taqsima 4 għal lista sħiħa ta' dawn l-effetti sekondarji.
English: IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL-23 induces the T helper 17 (Th17) pathway.
Maltese: IL-12 u IL-23 huma cytokines eterodimeriċi li huma mnixxija minn ċelloli attivati li jippreżentaw l-antiġen, bħal ma huma l-makrofaġi u ċ-ċelloli tad-dendrite, u ż-żewġ cytokines jipparteċipaw fil-funzjonijiet immuni; IL-12 tistimula ċ-ċelluli qattiela naturali (NK - natural killer) u tikkontrolla d-differenzjazzjoni ta' ċelluli CD4 + T lejn il-fenotip T helper 1 (Th1), IL-23 tinduċi l-passaġġ helper T 17 (Th17).
English: Immunomodulators and/or corticosteroids may be continued during treatment with STELARA.
Maltese: Immunomodulaturi u/jew kortikosterojdi tistgħu jitkomplew waqt it-trattament bi STELARA.
English: Number of patients ≤ 100 kg PASI 75 response N (%) 12 (4%) 218 (73%) 225 (78%) 217 (76%) 226 (81%) Number of patients > 100 kg 120 PASI 75 response N (%) 3 (3%) 55 (49%) 86 (71%) 59 (54%) 88 (74%)
Maltese: Rispons PASI 75 N (%) 12 (4%) 218 (73%) 225 (78%) 217 (76%) 226 (81%) Numru ta' pazjenti > 100 kg 120 Rispons PASI 75 N (%)
English: • If you are 65 years of age or over - you may be more likely to get infections.
Maltese: • Jekk għandek 65 sena jew iktar - jista' jkun li jkun aktar probabbli li int tieħu infezzjonijiet
English: The rate of infection was 0.91 per patient-year of follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02 per patient-year of follow-up in ustekinumab-treated patients (199 serious infections in 11,581 patient-years of follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, gastroenteritis and viral infections.
Maltese: Ir-rata ta' infezzjoni kienet 0.91 għal kull sena ta' sorveljanza wara l-kura ta' pazjent fil-pazjenti kkurati b'ustekinumab, u r-rata ta' infezzjonijiet serji kienet ta' 0.02 għal kull sena ta' sorveljanza wara l-kura ta' pazjent fil-pazjenti kkurati b'ustekinumab (199 infezzjoni serja f'11,581 sena ta' sorveljanza wara l-kura ta' pazjenti) u infezzjonijiet serji rrapportati kienu jinkludu pulmonite, axxess fl-anus, ċellulite, pulmonite, divertikulite, gastroenterite u infezzjonijiet virali.
English: Patients with a CDLQI > 1 at baseline
Maltese: Pazjenti bi CDLQI > 1 fil-linja bażi
English: The proportion of patients with a PGA score of cleared (0) or minimal (1) at week 12 was 77.3%.
Maltese: Il-proporzjon ta' pazjenti b'punteġġ PGA ta' fieqet (0) jew hija minima (1) f'ġimgħa 12 kien 77.3%.
English: Stelara.
Maltese: Tużax Stelara
English: The incidence of malignancies reported in ustekinumab-treated patients was comparable to the incidence expected in the general population (standardised incidence ratio = 0.93 [95% confidence interval: 0.71, 1.20], adjusted for age, gender and race).
Maltese: L-inċidenza ta' tumuri malinni rrappurtata f'pazjenti kkurati b'ustekinumab kienet tixbah l-inċidenza mistennija fil-popolazzjoni ġenerali (proporzjon ta' inċidenza standardizzat = 0.93 [95% intervall ta' kunfidenza: 0.71, 1.20], aġġustat għall-età, sess u razza).
English: Similar proportions of adult patients developed protective levels of anti-pneumococcal and anti-tetanus antibodies and antibody titers were similar among STELARA-treated and control patients.
Maltese: Proporzjonijiet simili ta' pazjenti adulti żviluppaw livelli protettivi ta' antikorpi kontra pnewmokokku u tetnu, u livelli ta' antikorpi kienu simili fost pazjenti kkurati b'STELARA u pazjenti ta' kontroll.