FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Xiapex can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Xiapex jista' jinsab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Xiapex
Maltese: Informazzjoni oħra dwar Xiapex
English: It contains the active substance collagenase clostridium histolyticum.
Maltese: Dan fih is-sustanza attiva kollaġenażi tal-clostridium histolyticum.
English: In the second study the figures were 44% (20 out of 45) for the Xiapex group and 5% (1 out of 21) for the placebo group.
Maltese: Fit-tieni studju, il-figuri kienu ta' 44% (20 minn 45) għall-grupp ta' Xiapex u 5% (1 minn 21) għall-grupp tal-plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Xiapex.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Xiapex.
English: What is Xiapex?
Maltese: Xiapex?
English: Among patients who completed the first study, 64% (130 out of 203) of those receiving Xiapex could straighten their fingers to an angle of 5 degrees or less compared with 7% (7 out of 103) of patients receiving placebo.
Maltese: Fost il-pazjenti li temmew l-ewwel studju, 64% (130 minn 203) ta' dawk li kienu qed jirċievu Xiapex setgħu jiddrittaw is-swaba' tagħhom sa angolu ta' 5 gradi jew inqas meta mqabbla ma' 7% (7 minn 103) tal-pazjenti li rċevew il-plaċebo.
English: Xiapex was also more effective than placebo in treating Peyronie's disease, producing a 38% and 31% improvement in abnormal curvature in the two studies, compared with 21% and 15% respectively for placebo.
Maltese: Xiapex kien ukoll iktar effettiv mill-plaċebo fil-kura tal-marda ta' Peryonie, u pproduċa titjib ta' 38% u ta' 31% fil-kurvatura mhux normali fiż-żewġ studji, meta mqabbel ma' 21% u 15% rispettivament għall-plaċebo.
English: Xiapex collagenase clostridium histolyticum
Maltese: Sommarju tal-EPAR għall-pubbliku kollaġenażi tal-clostridium histolyticum
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xiapex on 28 February 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Xiapex fit-28 ta' Frar 2011.
English: Why has Xiapex been approved?
Maltese: Għaliex ġie approvat Xiapex?
English: Xiapex was compared with placebo (a dummy treatment) in two main studies involving a total of 374 adult patients with Dupuytren's contracture.
Maltese: Xiapex tqabbel ma' plaċebo (kura finta) f'żewġ studji prinċipali li fihom ħadu sehem total ta' 374 pazjent adult bil-kontrazzjoni ta' Dupuytren.
English: What is the risk associated with Xiapex?
Maltese: X'inhu r-riskju assoċjat ma' Xiapex?
English: Xiapex is used to treat Dupuytren's contracture and Peyronie's disease in adults.
Maltese: Xiapex jintuża fil-kura tal-kontrazzjoni ta' Dupuytren u l-marda ta' Peyronie fl-adulti.
English: For Peyronie's disease, Xiapex was compared with placebo in two further studies involving 832 men.
Maltese: Għall-marda ta' Peryonie, Xiapex tqabbel ma' plaċebo f'żewġ studji oħrajn li involvew 832 raġel.
English: The collagenases in Xiapex are extracted from the bacterium Clostridium histolyticum.
Maltese: Il-kollaġenażijiet f'Xiapex huma estratti mill-batterju Clostridium histolyticum.
English: Peyronie's disease is a condition in which men develop plaques of fibrous, scar-like tissue in their penis, causing it to become abnormally curved, and sometimes leading to pain or difficulty in sexual intercourse.
Maltese: Il-marda ta' Peyronie hija kundizzjoni li fiha l-irġiel jiżviluppawlhom plakek ta' tessut fibruż simili għal ċikatriċi mal-pene tagħhom, u din twassal sabiex il-pene jiġi mgħawweġ b'mod mhux normali, u xi drabi ġġib magħha uġigħ jew diffikultà waqt l-att sesswali.
English: Up to 2 cords or 2 affected joints in the same hand can be treated at a time.
Maltese: Fl-istess id jistgħu jiġu kkurati sa 2 kordi jew 2 ġogi affetwati fl-istess ħin.
English: For more information on the use of Xiapex, including instructions on finger extension and penile modeling procedures, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar l-użu ta' Xiapex, inkluż struzzjonijiet dwar l-estensjoni bis-swaba' u proċeduri ta' mmudellar tal-pene, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: The most common side effects seen with Xiapex were local injection site reactions such as swelling, bruising, bleeding and pain.
Maltese: L-effetti sekondarji l-aktar komuni li dehru b'Xiapex kienu reazzjonijiet lokali fis-sit tal-injezzjoni bħal nefħa, tbenġil, emorraġija u wġigħ.
English: In each cycle, the dose of Xiapex is injected into the plaque causing the deformity followed by a second injection given 1 to 3 days after the first.
Maltese: F'kull ċiklu, id-doża ta' Xiapex tiġi injettata fil-plakka li tkun qed tikkawża d-deformità segwita bit-tieni injezzjoni mogħtija 1 jum sa 3 ijiem wara l-ewwel waħda.
English: The cords in the palm of patients with Dupuytren's contracture and the plaques in Peyronie's disease are made of fibres of a protein called collagen.
Maltese: Il-kordi fil-keff tal-id ta' pazjenti bil-kontrazzjoni ta' Dupuytren u l-plakek fil-marda ta' Peryonie huma magħmula minn fibri ta' proteina li jissejħu collagen.
English: For the full list of all side effects and restrictions with Xiapex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizjonijiet kollha bi Xiapex, ara l-fuljett ta' tagħrif.
English: Xiapex is a powder and solvent that are made up into a solution for injection.
Maltese: Il-mediċina tista' tinkiseb biss bi preskirzzjoni medika.
English: A ‘penile modeling procedure' is then performed by the doctor after a further 1 to 3 days to gently stretch and bend the plaque in the opposite direction to the abnormal curvature.
Maltese: Imbagħad issir ‘proċedura ta' mmudellar tal-pene” mit-tabib wara 1 sa 3 ijiem oħra biex b'ġentilezza tiġġebbed u titgħawweg il-plakka fid-direzzjoni opposta tal-kurvatura anormali.
English: How has Xiapex been studied?
Maltese: Kif ġie studjat Xiapex?
English: A risk management plan has been developed to ensure that Xiapex is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Xiapex jintuża bl-aktar mod sigur possibbli.
English: Xiapex is used in patients with plaques that can be felt through the skin and in whom the abnormal curvature of the penis is at least 30 degrees at the start of therapy.
Maltese: Xiapex jintuża f'pazjenti bi plakek li jistgħu jinħassu mill-ġilda u li fihom, il-kurvatura mhux normali tal-pene hija tal-inqas 30 grad fil-bidu tatterapija.
English: The company that markets Xiapex must also ensure that all doctors expected to use the medicine are properly trained on the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or Peyronie's disease.
Maltese: Għall-kontrazzjoni ta' Dupuytren, it-tabib jinjetta d-doża adegwata ta' Xiapex direttament ġo korda filkeff tal-id tal-pazjent.
English: Xiapex must be given by a doctor trained in the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or male genital problems.
Maltese: Il-kumpanija għandha tħejji programm edukattiv għat-tobba dwar l-użu tajjeb u l-effetti sekondarji potenzjali assoċjati malmediċina.
English: Patients received up to 4 treatment cycles, each involving two injections and subsequent modeling procedures, and the effects were measured on follow-up after 1 year.
Maltese: Ilpazjenti rċevew sa 4 ċikli ta' kura, kull waħda tinvolvi żewġ injezzjonijiet u proċeduri ta' mudellar sussegwenti, u l-effetti tkejlu fis-segwitu wara sena.
English: For patients with Peyronie's disease, Xiapex is given for up to 4 treatment cycles each lasting about 6 weeks.
Maltese: Għall-pazjenti bil-marda ta' Peyronie, Xiapex jingħata għal massimu ta' 4 ċikli ta' kura li kull waħda minnhom iddum madwar 6 ġimgħat.
English: If injection and finger extension have not brought about a satisfactory response, the procedure may be repeated at monthly intervals up to a maximum of 3 injections per cord.
Maltese: Jekk injezzjoni u estensjoni tas-swaba' ma jagħtux riżultat sodisfaċenti, il-proċedura tista' tiġi ripetuta f'intervalli ta' xahar sa massimu ta' tliet injezzjonijiet f'kull korda.
English: Xiapex must not be used to treat Peyronie's disease if the plaque affects the urethra (the tube that carries urine and semen to the outside).
Maltese: Xiapex m'għandux jintuża fil-kura tal-marda ta' Peryonie jekk il-plakka taffetwa l-uretra (it-tubu li jieħu l-awrina u s-semen għal barra).
English: The CHMP decided that Xiapex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Xiapex huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How does Xiapex work?
Maltese: X'inhu Xiapex?
English: Table 1: List of adverse reactions System Organ Class
Maltese: Tabella 1: Lista ta' reazzjonijiet avversi Klassi tas-Sistemi u tal-Organi
English: 2333CB Leiden The Netherlands
Maltese: 2333CB Leiden L-Olanda
English: Manufacturer Janssen Biologics B.V. Einsteinweg 101
Maltese: Manufattur Janssen Biologics B.V. Einsteinweg 101
English: Date of first authorisation: 10 November 2017
Maltese: Date tal-ewwel awtorizzazzjoni: 10 ta' Novembru 2017
English: Frequency ADR
Maltese: Frekwenza ADR
English: b, n (%) Week 16 21 (14.5) hf-PGA (N) hf-PGA 0/1
Maltese: b, n (%) Ġimgħa 16 21 (14.5) hf-PGA (N) hf-PGA 0/1
English: Clinically important active infections (e.g., active tuberculosis, see section 4.4).
Maltese: Infezzjonijiet attivi li jkunu klinikament importanti (eż., tuberkulożi attiva, ara sezzjoni 4.4).
English: EU/1/17/1234/001 1 pre-filled syringe EU/1/17/1234/002 1 pre-filled pen EU/1/17/1234/003 2 pre-filled pens EU/1/17/1234/004 2 pre-filled syringes
Maltese: EU/1/17/1234/001 siringa waħda mimlija għal-lest EU/1/17/1234/002 pinna waħda mimlija għal-lest EU/1/17/1234/003 2 pinnen mimlija għal-lest EU/1/17/1234/004
English: VOYAGE 1 and VOYAGE 2
Maltese: VOYAGE 1 u VOYAGE 2
English: • if you have an active infection, including active tuberculosis
Maltese: • jekk inti għandek infezzjoni attiva, inkluż tuberkulożi attiva
English: VOYAGE 2 Placebo Guselkumab Adalimumab Placebo Guselkumab Adalimumab ss-IGA (N) ss-IGA 0/1
Maltese: VOYAGE 2 Plaċebo Guselkumab Adalimumab Plaċebo Guselkumab Adalimumab ss-IGA (N) ss-IGA 0/1
English: b, n (%) Week 16 f-PGA (N) f-PGA 0/1, n (%) Week 16 14 (15.9) NAPSI (N) Percent Improvement, mean (SD) Week 16 -0.9 (57.9) 34.4 (42.4)
Maltese: b, n (%) Ġimgħa 16 6 (14.0) f-PGA (N) f-PGA 0/1, n (%) Ġimgħa 16 14 (15.9) NAPSI (N) Perċentwal ta' Titjib, medja (SD) Ġimgħa 16 -0.9 (57.9) 34.4 (42.4)
English: Through Week 156, 4.9% of all Tremfya-treated patients reported gastroenteritis.
Maltese: Sa Ġimgħa 156, 4.9% tal-pazjenti kollha trattati bi Tremfya rrappurtaw gastroenterite.
English: Symptom score = 0, n (%)
Maltese: Punteġġ tas-sintomi = 0, n (%)
English: PASI 90 response (48% vs 23%, respectively, p < 0.001).
Maltese: 3%, rispettivament; p = 0.001) u rispons PASI 90 (48% vs 23%, rispettivament, p < 0.001).
English: It is normal to see a drop of liquid.
Maltese: Huwa normali li tara qatra likwidu.
English: VOYAGE 2 Placebo Guselkumab Adalimumab Placebo Guselkumab Adalimumab
Maltese: VOYAGE 2 Plaċebo Guselkumab Adalimumab Plaċebo Guselkumab Adalimumab
English: There is limited information in subjects aged ≥ 65 years.
Maltese: Hemm informazzjoni limitata f'individwi li għandhom ≥ 65 sena.
English: Tremfya 100 mg injection guselkumab SC
Maltese: Tremfya 100 mg injezzjoni guselkumab SC
English: p < 0.001 for superiority p < 0.001 for non-inferiority, p=0.062 for superiority formal statistical testing was not performed
Maltese: p < 0.001 għal superjorità p < 0.001 għal nuqqas ta' inferjorità, p=0.062 għal superjorità ma sarx ittestjar statistiku formali
English: Tremfya may increase the risk of infection.
Maltese: Tremfya jista' jżid ir-riskju ta' infezzjoni.
English: • 1 Alcohol swab
Maltese: • Imselħa 1 bl-alkoħol
English: EU/1/17/1234/003 (2 packs, each containing 1 pre-filled pen)
Maltese: EU/1/17/1234/003 (2 pakketti, li kull wieħed fih pinna 1 mimlija għal-lest)
English: Store in refrigerator at 2° to 8°C.
Maltese: Aħżen fi friġġ f'temperatura ta' 2°sa 8°C.
English: Safety guard activates
Maltese: Il-protezzjoni ta' sigurtà tiġi attivata
English: In a Phase 1 study in subjects with moderate to severe plaque psoriasis, changes in systemic exposures (Cmax and AUCinf) of midazolam, S-warfarin, omeprazole, dextromethorphan, and caffeine after a single dose of guselkumab were not clinically relevant, indicating that drug interactions between guselkumab and substrates of various CYP enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) are unlikely.
Maltese: Fi studju ta' Fażi 1 f'individwi bi psorjasi bil-plakka minn moderata sa severa, bidliet fl-esponimenti sistemiċi (Cmax u AUCinf) ta' midazolam, S-warfarin, omeprazole, dextromethorphan, u kafeina wara doża waħda ta' guselkumab ma kinux rilevanti b'mod kliniku, li jindika li interazzjonijiet ta' bejn mediċini bejn guselkumab u sustrati ta' diversi enzimi ta' CYP (CYP3A4, CYP2C9, CYP2C19, CYP2D6, u CYP1A2) huma improbabbli.
English: Herpes simplex infections
Maltese: Infezzjonijiet bil-Herpes simplex
English: Name and address of the manufacturer responsible for batch release Janssen Biologics B.V.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Janssen Biologics B.V.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC16.
Maltese: Immunosoppressanti, inibituri ta' interleukin, kodiċi ATC:
English: Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Maltese: Eċċipjenti: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, ilma għallinjezzjonijiet.
English: All patients (N=871) received open-label ustekinumab (45 mg ≤100 kg and 90 mg >100 kg) at Weeks 0 and 4.
Maltese: Il-pazjenti kollha (N=871) flimkien mal-investigaturi kienu jafu li qed jingħataw ustekinumab (45 mg ≤ 100 kg u 90 mg > 100 kg) fil-ġimgħat 0 u 4.
English: Guselkumab was superior to secukinumab as measured by the primary endpoint of PASI 90 response at Week 48 (84.5% versus 70.0%, p < 0.001).
Maltese: Guselkumab kien superjuri għal secukinumab kif imkejjel mill-skop finali primarju tar-rispons PASI f'Ġimgħa 48 (84.5% versus 70.0%, p < 0.001).
English: Number of patients (%) Guselkumab (N=534)
Maltese: Numru ta' pazjenti (%) Guselkumab (N=534)
English: Patients were randomised to receive guselkumab (N=534; 100 mg at Week 0, 4 and q8w thereafter), or secukinumab (N=514; 300 mg at Week 0, 1, 2, 3, 4, and q4w thereafter).
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju biex jirċievu guselkumab (N=534; 100 mg f'Ġimgħa 0, 4 u q8w wara dan), jew secukinumab (N=514; 300 mg f'Ġimgħa 0, 1, 2, 3, 4, u q4w wara dan).
English: The adverse reactions are classified by MedDRA System Organ Class and frequency, using the following convention: 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).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont il-Klassi tas-Sistemi u talOrgani MedDRA u l-frekwenza, bl-użu tal-konvenzjoni li ġejja: 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 magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: In VOYAGE 2, 88.6% of patients receiving guselkumab maintenance treatment at Week 48 were PASI 90 responders compared to 36.8% of patients who were withdrawn from treatment at Week 28 (p < 0.001).
Maltese: F'VOYAGE 2, 88.6% tal-pazjenti li kienu qed jirċievu trattament ta' manteniment b'guselkumab f'Ġimgħa 48 rrispondew għal PASI 90 meta mqabbla ma' 36.8% tal-pazjenti li twaqqfilhom ittrattament f'Ġimgħa 28 (p < 0.001).
English: In two phase III clinical studies through the placebo-controlled period, gastroenteritis occurred more frequently in the Tremfya-treated group (1.1%) than in the placebo group (0.7%).
Maltese: III sal-perjodu ikkontrollat bil-plaċebo, gastroenterite seħħet aktar frekwenti fil-grupp ittrattat bi Tremfya (1.1%) milli fil-grupp tal-plaċebo (0.7%).
English: Two studies (VOYAGE 1 and VOYAGE 2) evaluated the efficacy and safety of guselkumab versus placebo and adalimumab in 1829 adult patients.
Maltese: Żewġ studji (VOYAGE 1 u VOYAGE 2) stmaw l-effikaċja u s-sigurtà ta' guselkumab versus plaċebo u adalimumab f'1,829 pazjent adult.
English: Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity.
Maltese: Guselkumab huwa antikorp monoklonali (mAb, monoclonal antibody) IgG1λ uman li jintrabat b'mod selettiv mal-proteina interleukin 23 (IL-23) bi speċifiċità u affinità kbira.
English: IL-23, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease.
Maltese: IL-23, ċitokin regulatorju, jaffettwa d-divrenzjar, l-espansjoni u s-sopravivenza ta' sottosettijiet taċ-ċelluli T, (eż., ċelluli Th17 u ċelluli Tc17) u sottosettijiet ta' ċelluli immuni naturali, li jirrapreżentaw sorsi ta' ċitokini li jirrispondu għal stimulu, inkluż IL-17A, IL-17F u IL-22 li huma l-forza wara l-mard infjammatorju.
English: Of all patients included in VOYAGE 1 and 2, 32% and 29% were naïve to both conventional systemic and biologic therapy, 54% and 57% had received prior phototherapy, and 62% and 64% had received prior conventional systemic therapy, respectively.
Maltese: Mill-pazjenti kollha li ġew inklużi f'VOYAGE 1 u 2, 32% u 29% ma kienu qatt ħadu kemm terapija konvenzjonali sistemika kif ukoll bijoloġika, 54% u 57% kienu rċivew fototerapija qabel, u 62% u 64% kienu rċivew terapija sistemika konvenzjonali qabel, rispettivament.
English: Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: G1 lamda (IgG1λ) kollu kemm hu uman għall-proteina interleukin (IL)-23, magħmul fiċ-ċelluli tal-Ovarju talĦamster Ċiniż (CHO, Chinese Hamster Ovary) permezz ta' teknoloġija rikombinanti tad-DNA.
English: Of the 1384 plaque psoriasis patients exposed to guselkumab and included in the population pharmacokinetic analysis, 70 patients were 65 years of age or older, including 4 patients who were 75 years of age or older.
Maltese: Mill-1,384 pazjent bi psorjasi bil-plakka esposti għal guselkumab u inklużi fl-analiżi farmakokinetika tal-popolazzjoni, 70 pazjent kellhom 65 sena jew aktar, inkluż 4 pazjenti li kellhom 75 sena jew aktar.
English: Symptom score = 0, n (%) PSSD Sign score, subjects with baseline score > 0
Maltese: Punteġġ tas-sintomi = 0, n (%) Punteġġ tas-sinjai PSSD, individwi b'punteġġ fil-linja bażi > 0
English: Name and address of the manufacturers of the biological active substance Biogen Inc. (BIIB)
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Biogen Inc.
English: Differences in response rates between guselkumab and ustekinumab treated patients were noted as early as 4 weeks after randomisation (11.1% and 9.0%, respectively) and reached a maximum 24 weeks after randomisation (see Figure 3).
Maltese: Differenżi fir-rati ta' rispons bejn pazjenti ttrattati b'guselkumab u ustekinumab ġew innutati sa minn 4 ġimgħat wara l-għażla arbitrarja (11.1% u 9.0%, rispettivament) u laħqu massimu 24 ġimgħa wara l-għażla arbitrarja (ara Figura 3).
English: What Tremfya contains - The active substance is guselkumab.
Maltese: X'fih Tremfya - Is-sustanza attiva hija guselkumab.
English: Instructions for use Tremfya
Maltese: Instruzzjonijiet dwar l-użu Tremfya
English: p < 0.001 for comparison between guselkumab and adalimumab.
Maltese: p < 0.001 għat-tqabbil bejn guselkumab u adalimumab.
English: Baseline disease characteristics were consistent for the study populations in VOYAGE 1 and 2 with a median body surface area (BSA) of 22% and 24%, a median baseline PASI score of 19 for both studies, a median baseline dermatology quality of life index (DLQI) score of 14 and 14.5, a baseline investigator global assessment (IGA) score of severe for 25% and 23% of patients, and a history of psoriatic arthritis for 19% and 18% of patients, respectively.
Maltese: Il-karatteristiċi tal-marda fil-linja bażi kienu konsistenti għall-popolazzjonijiet tal-istudju f'VOYAGE 1u 2 b'erja tas-superfiċje tal-ġisem (BSA) medjana ta' 22% u 24%, punteġġ medjan ta' PASI fil-linja bażi ta' 19 għaż-żewġ studji, punteġġ medjan tal-indiċi dermatoloġiċi tal-kwalità talħajja (DLQI, dermatology quality of life index) fil-linja bażi ta' 14 u 14.5, punteġġ tal-istima globali tal-investigatur (IGA, investigator global assessment) fil-linja bażi ta' sever għal 25% u 23% talpazjenti, u storja ta' artrite psorjatika għal 19% u 18% tal-pazjenti, rispettivament.
English: Figure 3: Percent of Subjects Who Achieved an IGA Score of Cleared (0) or Minimal (1) and at least a 2-grade improvement in IGA from Week 0 Through Week 24 by Visit After Randomisation in NAVIGATE
Maltese: Figura 3: Perċentwal ta' Individwi Li Kisbu Punteġġ IGA ta' ‘Imfejqa' (0) jew ‘Minima' (1) u titjib ta' mill-inqas grad 2 f'IGA minn Ġimgħa 0sa Ġimgħa 24 skont il-Vista Wara
English: Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea.
Maltese: Xi każijiet seħħew diversi jiem wara trattament b'guselkumab, inklużi każijiet b'urikarja u dispnea.
English: - The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80,
Maltese: - Is-sustanzi l-oħra huma histidine, histidine monohydrochloride monohydrate, polysorbate 80,
English: In VOYAGE 1 and 2, significant improvements were seen in scalp, hand and foot, and nail psoriasis (as measured by the Scalp-specific Investigator Global Assessment [ss-IGA], Physician's Global Assessment of Hands and/or Feet [hf-PGA], Fingernail Physician's Global Assessment [f-PGA] and Nail Psoriasis Severity Index [NAPSI], respectively) in guselkumab treated patients compared to placebo treated patients at Week 16 (p < 0.001, Table 3).
Maltese: F'VOYAGE 1 u 2, deher titjib sinifikanti fil-psorjasi tal-qurriegħa, tal-id u s-sieq u tad-dwiefer (imkejjel skont l-Istima Globali minn Investigatur speċifika għall-Qurriegħa [ss-IGA, Scalp-specific Investigator Global Assessment], Stima Globali tat-Tabib tal-Idejn u/jew is-Saqajn [hf-PGA Physician's Global Assessment of Hands and/or Feet], Stima Globali tat-Tabib tad-Dwiefer [f-PGA, Fingernail Physician's Global Assessment] u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer [NAPSI, Nail Psoriasis Severity Index], rispettivament) fil-pazjenti ttrattati b'guselkumab imqabbla ma' pazjenti ttrattati bil-plaċebo f'Ġimgħa 16 (p < 0.001, Tabella 3).
English: Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Maltese: Tremfya huwa indikat għat-trattament ta' psorjasi bil-plakka minn moderata sa severa f'adulti li huma kandidati għal terapija sistemika.
English: Concomitant immunosuppressive therapy or phototherapy The safety and efficacy of Tremfya in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Maltese: Is-sigurtà u l-effikaċja ta' Tremfya mogħti flimkien ma' immunosoppressanti, inkluż sustanzi bijoloġiċi, jew fototerapija ma ġewx ivvalutati.
English: Adverse reactions of gastroenteritis were non-serious and did not lead to discontinuation of Tremfya through Week 156.
Maltese: Reazzjonijiet avversi ta' gastroenterite ma kinux serji u ma wasslux għat-twaqqif ta' Tremfya sa Ġimgħa 156.