FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions with CYP450 substrates
Maltese: Interazzjonijiet ma' sustrati taċ-ċitokrom P450
English: How to use Tremfya
Maltese: Tużax Tremfya
English: Following a single 100 mg subcutaneous injection in healthy subjects, guselkumab reached a mean (± SD) maximum serum concentration (Cmax) of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post dose.
Maltese: Wara injezzjoni waħda ta' 100 mg taħt il-ġilda f'individwi f'saħħithom, guselkumab laħaq medja (± SD) tal-ogħla konċentrazjoni fis-serum (Cmax) ta' 8.09 ± 3.68 mcg/mL sa madwar 5.5 ijiem wara ddoża.
English: Place on skin
Maltese: U LUŻU
English: In VOYAGE 2, among 112 patients randomised to adalimumab who failed to achieve a PASI 90 response at Week 28, 66% and 76% achieved a PASI 90 response after 20 and 44 weeks of treatment with guselkumab, respectively.
Maltese: F'VOYAGE 2, fost il-112-il pazjent li ntagħżlu b'mod arbitrarju għal adalimumab li ma rnexxielhomx jiksbu rispons PASI 90 f'Ġimgħa 28, 66% u 76% kisbu rispons PASI 90 wara 20 u 44 ġimgħa ta' trattament b'guselkumab, rispettivament.
English: At Week 16, 268 patients with an IGA ≥ 2 score were randomised to either continue ustekinumab treatment (N=133) q12w, or to initiate guselkumab treatment (N=135) at Weeks 16, 20, and q8w thereafter.
Maltese: Fil-Ġimgħa 16, 268 pazjent b'punteġġ IGA ≥ 2 intagħżlu b'mod arbitrarju biex jew jirċievu trattament b'ustekinumab (N=133) q12w, jew biex jibdew trattament b'guselkumab (N=135) fil-Ġimgħat 16, 20, u q8w wara dak iżżmien.
English: Includes only subjects with ss-IGA, f-PGA, hf-PGA score ≥ 2 at baseline or baseline NAPSI score > 0.
Maltese: Tinkludi biss individwi b'punteġġ ≥ 2 għal ss-IGA, f-PGA, hf-PGA fil-linja bażi jew punteġġ ta' > 0 għal NAPSI fillinja bażi.
English: Some side effects are common (may affect up to 1 in 10 people): - headache - joint pain (arthralgia) - diarrhoea - stomach flu (gastroenteritis) - redness at the injection site - hives - fungal infection of the skin, for instance between the toes (e.g., athlete's foot) - herpes simplex infections
Maltese: Xi effetti sekondarji huma komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10 ): - uġigħ ta' ras - uġigħ fil-ġogi (artralġja) - dijarea - mikrobu fl-istonku (gastroenterite) - ħmura fil-post tal-injezzjoni - ħorriqija - infezzjoni bil-fungu fil-ġilda, per eżempju bejn is-swaba tas-sieq (eż., athlete's foot) - infezzjonijiet b'herpes simplex
English: Week 156
Maltese: Ġimgħa 156
English: • 1 Sharps container (See Step 3)
Maltese: • Kontenitur 1 għal oġġetti li jaqtgħu jew bil-ponta (Ara Pass 3)
English: Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
Maltese: Tremfya fih is-sustanza attiva guselkumab li huwa tip ta' proteina msejħa antikorp monoklonali.
English: sucrose and water for injections.
Maltese: sucrose u ilma għall-injezzjonijiet.
English: Serious allergic reactions, which can include symptoms of hives and shortness of breath, have occurred with Tremfya (see “Serious side effects” in section 4).
Maltese: Reazzjonijiet allerġiċi serji, li jistgħu jinkludu sintomi ta' ħorriqija u qtugħ ta' nifs, seħħew bi Tremfya (ara “Effetti sekondarji serji” f'sezzjoni 4).
English: Patients randomised to adalimumab (N=582) received 80 mg at Week 0 and 40 mg at Week 1, followed by 40 mg every other week (q2w) through Week 48 (VOYAGE 1) and Week 23 (VOYAGE 2).
Maltese: (N=582) irċivew 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 1, segwiti minn 40 mg darba kull ġimagħtejn (q2w) sa Ġimgħa 48 (VOYAGE 1) u Ġimgħa 23 (VOYAGE 2).
English: • 1 Cotton ball or gauze pad
Maltese: • Ballun 1 tajjar jew garża
English: For further instructions on preparation and special precautions for handling, see section 6.6 and the ‘Instructions for use' leaflet.
Maltese: Għal aktar istruzzjonijeit dwar il-preparazzjoni u prekawzjonijiet speċjali għall-immaniġġjar, ara sezzjoni 6.6 u l-fuljett tal-‘Instruzzjonijiet dwar l-użu'.
English: Summary of Regional Disease Responses in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Maltese: Tabella 2: Sommarju tar-Risponsi Kliniċi f'VOYAGE 1 u VOYAGE 2
English: CARTON FOR 1 PRE-FILLED SYRINGE (100 mg) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Maltese: KARTUNA GĦAL SIRINGA 1 MIMLIJA GĦAL-LEST (100 mg) BĦALA PAKKETT TANNOFS/KOMPONENT TA' PAKKETT B'ĦAFNA (MINGĦAJR IL-KAXXA Ċ-ĊELESTI)
English: Health-related quality of life / Patient reported outcomes Across VOYAGE 1 and 2 significantly greater improvements in health-related quality of life as measured by Dermatology Life Quality Index (DLQI) and in patient-reported psoriasis symptoms (itching, pain, burning, stinging and skin tightness) and signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) as measured by the Psoriasis Symptoms and Signs Diary (PSSD) were observed in guselkumab patients compared to placebo patients at Week 16 (Table 4).
Maltese: Kwalità tal-ħajja marbuta mas-saħħa / Riżultati rrappuratati mill-pazjenti Fl-istudji VOYAGE 1 u 2 ġie osservat titjib akbar b'mod sinifikanti fil-kwalità tal-ħajja marbuta massaħħa kif imkejjel permezz tal-Indiċi tal-Kwalità tal-Ħajja tad-Dermatoloġija (DLQI, Dermatology Life Quality Index) u fis-sintomi (ħakk, uġigħ, ħruq, tingiż u ġbid fil-ġilda) u s-sinjali (ġilda xotta, maqsuma, bil-qxur, titqaxxar jew jaqaw minnha biċċiet żgħar, ħmura u ħruġ ta' demm) tal-psorjasi rrappurtati mill-pazjenti kif imkejla permezz ta' Djarju tas-Sinjali u s-Sintomi tal-Psorjasi (PSSD, Psoriasis Symptoms and Signs Diary) fil-pazjenti ta' guselkumab meta mqabbla mal-pazjenti talplaċebo f'Ġimgħa 16 (Tabella 4).
English: Single intravenous doses of guselkumab up to 987 mg (10 mg/kg) have been administered in healthy volunteers and single subcutaneous doses of guselkumab up to 300 mg have been administered in patients with plaque psoriasis in clinical studies without dose-limiting toxicity.
Maltese: Dożi waħdiet ta' guselkumab sa 987 mg (10 mg/kg) ġew mogħtija fil-vini lill-individwi f'saħħithom u dożi waħdiet ta' guselkumab sa 300 mg ġew mogħtija taħt il-ġilda lill-individwi bi psorjasi bil-plakka fi studji kliniċi mingħajr tossiċità li tillimita d-doża.
English: Through Week 156, 0.5% of Tremfya injections were associated with injection site reactions.
Maltese: Sa Ġimgħa 156, 0.5% tal-injezzjnijiet ta' Tremfya kienu assoċjati ma' reazzjonijiet fil-post tal-injezzjoni.
English: Plunger locks
Maltese: NUMRU TAL-LOTT
English: Tremfya is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
Maltese: Tremfya mhuwiex irrakkomandat għal tfal u adolexxenti ta' taħt it-18-il sena minħabba li ma ġiex studjat f'dan il-grupp ta' età.
English: Week 76
Maltese: Ġimgħa 76
English: • if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions')
Maltese: • jekk taħseb li għandek infezzjoni jew sintomi ta' infezzjoni (ara aktar 'l isfel taħt ‘Oqgħod attent għal infezzjonijiet u reazzjonijiet allerġiċi')
English: Between 12 and 24 weeks after randomisation, guselkumab patients achieved an IGA score 0/1 with ≥ 2 grade improvement twice as often as ustekinumab patients (mean 1.5 vs 0.7 visits, respectively, p < 0.001).
Maltese: Bejn 12 u 24 ġimgħa wara l-għażla arbitrarja, il-pazjenti fuq guselkumab kisbu punteġġ IGA ta' 0/1 b'titjib ta'grad ≥ 2 darbtejn aktar spiss minn pazjenti fuq ustekinumab (medja 1.5 vs 0.7 visiti, rispettivament, p < 0.001).
English: How to store Tremfya 6.
Maltese: Kif taħżen Tremfya 6.
English: In VOYAGE 1, for patients receiving continuous guselkumab treatment, the PASI 90 response rate was maintained from Week 52 through Week 156.
Maltese: F'VOYAGE 1, għall-pazjenit li kienu qed jirċievu trattament kontinwu b'guselkumab, ir-rata ta' rispons PASI 90 inżammet minn Ġimgħa 52 sa Ġimgħa 156.
English: The mean (± SD) steady-state trough serum guselkumab concentrations in two phase III studies were 1.15 ± 0.73 mcg/mL and 1.23 ± 0.84 mcg/mL.
Maltese: III kienet 1.15 ± 0.73 mcg/mL u 1.23 ± 0.84 mcg/mL.
English: Baseline disease characteristics were consistent with a population of moderate to severe plaque psoriasis with a median BSA of 20%, a median PASI score of 18, and an IGA score of severe for 24% of patients.
Maltese: Il-karatterisitiċi tal-marda fil-linja bażi kienu konsistenti ma' popolazzjoni ta' psorjażi tal-plakka minn moderata sa severa b'BSA medjan ta' 20%, punteġġ PASI ta' 18, u punteġġ IGA ta' sever f'24% talpazjenti.
English: In pooled phase II and phase III analyses, fewer than 6% of patients treated with Tremfya developed antidrug antibodies in up to 52 weeks of treatment.
Maltese: III, anqas minn 6% tal-pazjenti ttrattati bi Tremfya żviluppaw antikorpi kontra l-mediċina sa 52 ġimgħa ta' trattament.
English: In addition, among 95 patients randomised to guselkumab who failed to achieve a PASI 90 response at Week 28, 36% and 41% achieved a PASI 90 response with an additional 20 and 44 weeks of continued treatment with guselkumab, respectively.
Maltese: Barra dan, fost il-95 pazjent li ntagħżlu b'mod arbitrarju għal guselkumab li ma kisbux rispons PASI 90 f'Ġimgħa 28, 36% u 41% kisbu rispons PASI 90 b'20 u 44 ġimgħa ta' trattament kontinwu addizzjonali b'guselkumab, rispettivament.
English: Serious hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva serja għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Pre-filled syringe at-a-glance
Maltese: Agħfas il-planġer
English: In humans, selective blockade of IL-23 was shown to normalize production of these cytokines.
Maltese: Fil-bnedmin, l-imblokk selettiv ta' IL-23 intwera li jinnormalizza l-produzzjoni ta' dawn iċ-ċitokini.
English: In VOYAGE 2, guselkumab patients had significantly greater improvement from baseline compared to placebo in health-related quality of life, anxiety and depression, and work limitation measures at Week 16, as measured by the 36-item Short Form (SF-36) health survey questionnaire, Hospital Anxiety and Depression Scale (HADS), and Work Limitations Questionnaire (WLQ), respectively.
Maltese: F'VOYAGE 2, pazjenti fuq guselkumab kellhom titjib akbar b'mod sinifikanti mil-linja bażi mqabbel mal-plaċebo fil-kwalità tal-ħajja marbuta mas-saħħa, fl-ansjetà u d-depressjoni u fil-miżuri li jillimitaw ix-xogħol f'Ġimgħa 16, kif imkejjel mill-kwestjonarju ta' stħarriġ dwar is-saħħa talFormola l-Qasira b'lista ta' 36 punt (SF-36, Short Form), l-Iskala tal-Ansjetà u d-Depressjoni talIsptar (HADS, Hospital Anxiety and Depression Scale), u l-Kwestjonarju tal-Limitazzjonijiet taxXogħol (WLQ, Work Limitations Questionnaire), rispettivament.
English: In both studies, patients randomised to placebo (N=422) received guselkumab 100 mg at Weeks 16, 20 and q8w thereafter.
Maltese: Fiż-żewġ studji, il-pazjenti li ntagħżlu b'mod arbitrarju għall-plaċebo (N=422) rċivew guselkumab 100 mg fil-Ġimgħat 16, 20 u q8w wara dak iż-żmien.
English: Pre-filled syringe
Maltese: Protezzjoni tal-Labra
English: Pre-filled pen at-a-glance
Maltese: Poġġi fuq il-ġilda
English: Renal elimination of intact guselkumab, an IgG mAb, is expected to be low and of minor importance; similarly, hepatic impairment is not expected to influence clearance of guselkumab as IgG mAbs are mainly eliminated via intracellular catabolism.
Maltese: L-eliminazzjoni ta' guselkumab, IgG mAb, mhux mibdul millkliewi hija mistennija li tkun baxxa u ta' importanza żgħira; b'mod simili, indeboliment tal-fwied mhuwiex mistenni jinfluwenza t-tneħħija ta' guselkumab minħabba li IgG mAb huma l-biċċa l-kbira eliminati permezz ta' kataboliżmu intraċellulari.
English: Among patients who were withdrawn from treatment and subsequently re-initiated guselkumab, 80% regained a PASI 90 response when assessed 20 weeks after initiation of retreatment.
Maltese: Fost il-pazjenti li twaqqfu mit-trattament u sussegwentement reġgħu bdew trattament b'guselkumab, 80% reġgħu kisbu rispons PASI 90 meta ġew eżaminati 20 ġimgħa wara l-bidu tattratttament mill-ġdid.
English: In pooled phase III analyses, approximately 9% of patients treated with Tremfya developed antidrug antibodies in up to 156 weeks of treatment.
Maltese: III, madwar 9% tal-pazjenti ttrattati bi Tremfya żviluppaw antikorpi kontra l-mediċina f'sa 156 ġimgħa ta' trattament.
English: The systemic exposure of guselkumab (Cmax and AUC) increased in an approximately dose-proportional manner following a single subcutaneous injection at doses ranging from 10 mg to 300 mg in healthy subjects or patients with plaque psoriasis.
Maltese: L-esponiment sistemiku għal guselkumab (Cmax u AUC) żdied bejn wieħed u ieħor fi proporzjon maddoża wara doża waħda taħt il-ġilda b'dożi li varjaw minn 10 mg sa 300 mg f'individwi f'saħħithom jew f'pazjenti bi psorjasi bil-plakka.
English: PSSD Symptom Score, subjects with baseline score > 0
Maltese: Punteġġ tas-Sintomi PSSD, Individwi b'punteġġ > 0 fillinja bażi
English: Mean half-life (T1/2) of guselkumab was approximately 17 days in healthy subjects and approximately 15 to 18 days in patients with plaque psoriasis across studies.
Maltese: Il-medja tal-half-life (T1/2) ta' guselkumab kienet madwar 17-il jum f'individwi f'saħħithom u madwar 15 sa 18-il jum f'pazjenti bi psorjasi bil-plakka fl-istudji kollha.
English: As a human IgG mAb, guselkumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Maltese: Bħala IgG mAb uman, guselkumab huwa mistenni li jitkisser f'peptidi żgħar u aċidi amminiċi permezz ta' sensiela ta' reazzjonijiet kataboliċi bl-istess mod bħal IgG endoġenu.
English: Guselkumab exerts clinical effects in plaque psoriasis through blockade of the IL-23 cytokine pathway.
Maltese: Guselkumab jinfluwenza effetti kliniċi fi psorjasi bil-plakka permezz talimblokk tas-sensiela ta' reazzjonijiet taċ-ċitokin IL-23.
English: A weekly subcutaneous dose of 50 mg/kg to monkeys resulted in exposure (AUC) and Cmax values that were at least 49-fold and >200-fold higher, respectively, than those measured in the human clinical PK study.
Maltese: Doża darba f'ġimgħa taħt il-ġilda ta' 50 mg/kg lixxadini wasslet għal esponiment (AUC) u valuri tas-Cmax li kienu mill-anqas 49 darba u >200 darba ogħla, rispettivament, minn dawk imkejla fl-istudju PK kliniku fil-bniedem.
English: Figure 4: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit (Subjects Randomised at Week 0) in ECLIPSE
Maltese: Figura 4: Perċentwal ta' Individwi li Kisbu Rispons PASI 90 sa Ġimgħa 48 skont il-Vista (Individwi li Ntagħżlu b'mod Arbitrarju f'Ġimgħa 0) f'ECLIPSE
English: Figure 2: Percent of Subjects Who Achieved a PASI 90 Response by Visit in the Open-Label Phase in VOYAGE 1
Maltese: Figura 2: Perċentwal ta' Individwi li Kisbu Rispons PASI 90
English: The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay.
Maltese: L-immunoġeniċita ta' Tremfya ġiet stmata bl-użu ta' immunoassaġġ sensittiv u tolleranti għallmediċina.
English: The efficacy and safety of guselkumab was assessed in three randomised, double-blind, active controlled phase III studies in adult patients with moderate to severe plaque psoriasis, who were candidates for phototherapy or systemic therapy.
Maltese: III fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża f'pazjenti adulti bi psorjasi bil-plakka minn moderata sa severa, li kienu kandidati għal fototerapija jew terapija sistemika.
English: Sign score = 0, n (%)
Maltese: Punteġġ tas-sinjali = 0, n (%) Ġimgħa 16
English: Patients with renal or hepatic impairment
Maltese: Indeboliment renali jew epatiku
English: The effect of guselkumab on human fertility has not been evaluated.
Maltese: Ma ġiex stmat l-effett ta' guselkumab fuq il-fertilità umana.
English: The percentage of patients achieving a PASI 90 response was numerically higher for guselkumab than adalimumab starting at Week 8 with the difference reaching a maximum around Week 20 (VOYAGE 1 and 2) and maintained through Week 48 (VOYAGE 1) (see Figure 1).
Maltese: Il-perċentwal ta' pazjenti li kisbu rispons PASI 90 kien numerikament ogħla għal guselkumab milli għal adalimumab li beda f'Ġimgħa 8 biddifferenza tilħaq il-massimu madwar Ġimgħa 20 (VOYAGE 1 u 2) u tinżamm sa Ġimgħa 48 (VOYAGE 1) (ara Figura 1).
English: In two phase III clinical studies through Week 48, 0.7% of Tremfya injections and 0.3% of placebo injections were associated with injection site reactions.
Maltese: III sa Ġimgħa 48, 0.7% tal-injezzjonijiet ta' Tremfya u 0.3% talinjezzjonijiet tal-plaċebo kienu assoċjati ma' reazzjonijiet fil-post tal-injezzjoni.
English: Additionally, there were no adverse immunotoxicity or cardiovascular safety pharmacology effects noted during the conduct of the repeat-dose toxicity studies or in a targeted cardiovascular safety pharmacology study in cynomolgus monkeys.
Maltese: Barra dan, ma ġew innutati l-ebda effett avversi ta' sigurtà farmakoloġika ta' tossiċità immuni jew kardjovaskulari meta saru l-istudji dwar tossiċità minn dożi ripetuti jew fi studju immirat għal sigurtà farmakoloġika kardjovaskulari f'xadini cynomolgus.
English: In VOYAGE 2, patients randomised to guselkumab at Week 0 who were Psoriasis Area and Severity Index (PASI) 90 responders at Week 28 were re-randomised to either continue treatment with guselkumab q8w (maintenance treatment) or receive placebo (withdrawal treatment).
Maltese: F'VOYAGE 2, il-pazjenti li ntagħżlu b'mod arbitrarju għal guselkumab f'Ġimgħa 0 li kienu wieġbu għal Indiċi taż-Żona u tal-Qawwa tal-Psorjasi (PASI, Psoriasis Area and Severity Index) 90 f'Ġimgħa 28 reġgħu ġew magħżula b'mod arbitrarju mill-ġdid biex jew ikomplu t-trattament b'guselkumab q8w (manteniment tat-trattament) jew jirċievu plaċebo (waqfien tat-trattament).
English: Mean systemic clearance (CL) following a single intravenous administration to healthy subjects ranged from 0.288 to 0.479 L/day across studies.
Maltese: Il-medja tat-tneħħija sistemika (CL, clearance) wara għoti ta' doża waħda fil-vini lil individwi f'saħħithom varjat minn 0.288 sa 0.479 L/kuljum fl-istudji kollha.
English: Patients randomised to adalimumab at Week 0 who were PASI 90 non-responders received guselkumab at Weeks 28, 32 and q8w thereafter.
Maltese: Il-pazjenti li ntagħżlu b'mod arbitrarju biex jirċievu adalimumab f'Ġimgħa 0 li ma kisbux ripons PASI 90 rċivew guselkumab fil-Ġimgħat 28, 32 u q8w wara dan.
English: Multipack: 2 (2 packs of 1) pre-filled pens
Maltese: 2 (2 pakketti ta' 1) pinnen mimlija għal-lest
English: Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Maltese: Tremfya jista' jtejjeb il-kundizzjoni tal-ġilda u d-dehra tad-dwiefer u jnaqqas is-sintomi, bħal ma huma ġilda bil-qxur, titqaxxar, jaqa' minnha frak, ħakk, uġigħ u ħruq.
English: In a phase I study, treatment with guselkumab resulted in reduced expression of IL-23/Th17 pathway genes and psoriasis-associated gene expression profiles, as shown by analyses of mRNA obtained from lesional skin biopsies of patients with plaque psoriasis at Week 12 compared to baseline.
Maltese: Fi studju ta' fażi I, it-trattament b'guselkumab wassal għal tnaqqis fl-espressjoni tal-ġeni tas-sensiela ta' reazzjonijiet ta' IL-23/Th17 u tal-profili tal-espressjoni tal-ġeni assoċjati mal-psorjasi, muri minn analiżi ta' mRNA miksuba minn bijopsiji ta' feriti fil-ġilda ta' pazjenti bi psorjasi bil-plakka f'Ġimgħa 12 imqabbla mal-linja bażi.
English: Tremfya can potentially cause serious side effects, including allergic reactions and infections.
Maltese: Oqgħod attent għal infezzjonijiet u reazzjonijiet allerġiċi Tremfya għandu possibbiltà li jikkawża effetti sekondarji serji, inklużi reazzjonijiet allerġiċi u infezzjonijiet.
English: The efficacy and safety of guselkumab was demonstrated regardless of age, gender, race, body weight, plaques location, PASI baseline severity, concurrent psoriatic arthritis, and previous treatment with a biologic therapy.
Maltese: L-effikaċja u s-sigurtà ta' guselkumab intweriet irrispettivament mill-età, mis-sess tal-persuna, mirrazza, mill-piż tal-ġisem, mill-postijiet tal-plakek tal-psorjasi, mis-severità ta' PASI fil-linja bażi, millartrite prorjatika fl-istess ħin, u mit-trattament preċedenti b'terapija bijoloġika.
English: These results are consistent with the clinical benefit observed with guselkumab treatment in plaque psoriasis.
Maltese: Dawn irriżultati huma konsistenti mal-benefiċċju kliniku osservat bit-trattament b'guselkumab fi psorjasi bilplakka.
English: Levels of IL-23 are elevated in the skin of patients with plaque psoriasis.
Maltese: Il-livelli ta' IL-23 kienu għoljin fil-ġilda ta' pazjenti bi psorjasi bil-plakka.
English: Table 1 provides a list of adverse reactions from psoriasis clinical studies as well as from post-marketing experience.
Maltese: Tabella 1 tipprovdi lista ta' rezzjonijiet avversi minn studji kliniċi tal-psorjasi kif ukoll minn esperjeza wara t-tqegħid fis-suq.
English: • The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin
Maltese: • Id-doża hija 100 mg (il-kontenut ta' siringa 1 mimlija għal-lest) mogħtija permezz ta' injezzjoni taħt il-ġilda.
English: Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 packs of 1) pre-filled syringes.
Maltese: Tremfya huwa disponibbli f'pakkett li fih siringa waħda mimlija għal-lest u f'pakkett b'ħafna li fih 2 (2 pakketti b'1) siringi mimlija għal-lest.
English: DLQI score > 1 at baseline, n Subjects with DLQI 0/1
Maltese: Punteġġ DLQI > 1 fil-linja bażi,
English: Figure 1: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit (Subjects Randomised at Week 0) in VOYAGE 1
Maltese: Figura 1: Perċentwal ta' Individiwi li kisbu Rispons PASI 90 sal-Ġimgħa 48 skont il-Vista (lIndividwi
English: No new safety findings were observed in patients who switched from ustekinumab to guselkumab.
Maltese: Ma kienu osservati lebda sejbiet ġodda ta' sigurtà f'pazjenti li qalbu minn adalimumab għal guselkumab.
English: The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks.
Maltese: Id-doża rrakkomandata ta' Tremfya hija 100 mg permezz ta' injezzjoni taħt il-ġilda fil-ġimgħat 0 u 4, segwita minn doża ta' manteniment kull 8 ġimgħat.
English: PASI 75 response at Week 12
Maltese: PASI 75 10 (5
English: Prescribers should consult the Summary of Product Characteristics of the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Maltese: Il-persuni li jordnawh għandhom jikkonsultaw is-Sommarju tal-Karatteristiċi tal-Prodott tat-tilqima speċifika għal informazzjoni u gwida addizzjonali dwar l-użu konkomitanti ta' sustanzi immunosoppressivi wara ttilqim.
English: Major Secondary Endpoints PASI 75 response at both Week 12 and Week 48
Maltese: Skop Finali Primarju Rispons PASI 90f'Ġimgħa 48 Punti finali sekondarji Maġġuri Rispons PASI 75 f'Ġimgħa 12 u f'Ġimgħa 48
English: Nagyenyed u. 8-14
Maltese: Ġimgħa 16
English: d.o.o.
Maltese: Tħawdux.
English: The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy subjects.
Maltese: Il-bijodisponibbiltà assoluta ta' guselkumab wara injezzjoni waħda ta' 100 mg taħt il-ġilda ġiet stmata li kienet madwar 49% f'individwi f'saħħithom.
English: Patients randomised to guselkumab (N=825) received 100 mg at Weeks 0 and 4, and every 8 weeks (q8w) thereafter through Week 48 (VOYAGE 1) and Week 20 (VOYAGE 2).
Maltese: Il-pazjenti li ntagħżlu b'mod arbitrarju biex jirċievu guselkumab (N=825) irċivew 100 mg fil-Ġimgħat 0 u 4, u kull 8 ġimgħat (q8w) wara dak iż-żmien sa Ġimgħa 48 (VOYAGE 1) u Ġimgħa 20 (VOYAGE 2).
English: Check the expiration date (‘EXP') on the back panel of the carton.
Maltese: Iċċekkja d-data ta' skadenza (‘JIS') fuq wara tal-kartuna.
English: If a serious hypersensitivity reaction occurs, administration of Tremfya should be discontinued immediately and appropriate therapy initiated.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI