FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) of Riluzole Zentiva are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Maltese: Effetti sekondarji oħra Effetti sekondarji komuni ħafna (jistgħu jolqtu iktar minn persuna 1 minn kull 10 ) ta' Riluzole
English: Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Maltese: Riluzole Zentiva jintuża f'pazjenti bl-atrofija tal-muskoli dovuta għall-isklerożi laterali (ALS).
English: The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Maltese: 13.5 xhur, għal riluzole 100 mg/jum u l-paċebo, rispettivament.
English: If you are less than 18 years of age, the use of Riluzole Zentiva is not recommended because there is no information available in this population.
Maltese: Jekk inti għandek inqas minn 18-il sena, l-użu ta' Riluzole Zentiva m'huwiex rakkomandat minħabba li m'hemmx informazzjoni disponibbli f'din il-popolazzjoni.
English: In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Maltese: Minn studji kliniċi, f'pazjenti (n=20) fejn kien hemm żidiet fil-ALT għal iżjed minn 5 darbiet il-ULN, ittrattament ġie mwaqqaf u f'ħafna drabi l-livelli ġew anqas minn darbtejn il-ULN f'perjodu ta' 2 sa 4
English: Riluzole Zentiva 50 mg film-coated tablets riluzole
Maltese: Riluzole Zentiva 50 mg pilloli miksija b'rita riluzole
English: Nausea
Maltese: Uġigħ
English: Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
Maltese: fil-waqt li indutturi ta' CYP 1A2 (e.g. id-duħħan tas-sigaretti, ikel mixwi fuq il-faħam, rifampicin u omeprazole) jistgħu jżidu r-rata tat-tneħħija ta' riluzole.
English: How to store Riluzole Zentiva
Maltese: Għalxiex jintuża Riluzole Zentiva?
English: Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Maltese: Riluzole Zentiva mhux irrakkomandat f'pazjenti li għandhom indeboliment renali, peress li qatt ma saru studji b'dożi repetuti f'dawn il-pazjenti (ara sezzjoni 4.4).
English: In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months.
Maltese: Fi prova fejn kienet investigata l-firxa tad-dożaġġi, 959 pazjent bl-ALS tqassmu, mingħajr għażla, f'wieħed minn erba' gruppi ta' kura: riluzole 50, 100, 200 mg/jum, jew plaċebo u kienu segwiti għal
English: GENERAL CLASSIFICATION FOR SUPPLY
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Each film-coated tablet contains 50 mg of riluzole.
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' riluzole.
English: In a trial, 155 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 12 to 21 months.
Maltese: Fi prova waħda, 155 pazjent kienu allokati mingħajr għażla biex jieħdu jew riluzole 100 mg/jum (50 mg darbtejn kuljum) jew il-plaċebo u kienu sorveljati għal 12 sa 21 xahar.
English: In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
Maltese: Fi studji ikkontrollati permezz tal-plaċebo, tat-tip double-blind, li sar biex jassessja l-effikaċja u s sigurtà ta' riluzole f'pazjenti Ġappuniżi, 204 pazjent kienu mqassmin, mingħajr għażla, biex jieħdu jew riluzole 100 mg/jum (50 mg darbtejn kuljum) jew il-plaċebo, u dawn kienu segwiti għal 18-il xahar.
English: Survival, as defined in the second paragraph of section 4.1, was significantly extended for patients who received riluzole as compared to patients who received placebo.
Maltese: Is-sopravivenza, kif definita fit-tieni paragrafu ta' sezzjoni 4.1, kienet itwal b'mod sinifikanti għall-pazjenti li ħadu riluzole meta mqabbla ma' dawk li ħadu l-plaċebo.
English: There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Maltese: M'hemm l-ebda evidenza li Riluzole Zentiva jeżerċita effett terapewtiku fuq il-movimenti tal-persuna, il-funzjoni tal-pulmuni, kontrazzjonijiet involontarji tal-muskoli, s-saħħa tal-muskoli jew sintomi riferibbli għall-moviment.
English: Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
Maltese: Kienu rapportati sintomi newroloġiċi u psikjatriċi, enċefalopatija tossika akuta bi sturdament, koma u metemoglobinimja f'każijiet iżolati.
English: Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole (see section 4.8).
Maltese: Indeboliment renali Studji b'dożi repetuti ma sarux f'pazjenti b'indeboliment fil-funzjoni renali (ara sezzjoni 4.2).
English: Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Maltese: 15 mg/kg/jum (li hija ogħla mid-doża terapewtika), probabbli minħabba ħedla u l-letarġija.
English: How to take Riluzole Zentiva
Maltese: Tiħux Riluzole Zentiva
English: Glucuronides accounted for more than 85% of the metabolites in the urine.
Maltese: Il-glucuronides jammontaw għall-aktar minn 85% tal-prodotti metaboliċi fl-awrina. 2% biss tad-doża ta' riluzole kienet irkuprata mhux mibdula fl-awrina.
English: Riluzole is proposed to act by inhibiting glutamate processes.
Maltese: Huwa suġġerit li riluzole jaġixxi billi jinibixxi il-proċessi dipendenti fuq glutamate.
English: Fertility
Maltese: Newtropenja
English: In this study the majority of patients had a vital capacity less than 60%.
Maltese: F'dan l-istudju, lmaġġoranza tal-pazjenti kellhom kapaċità vitali ta' inqas minn 60%.
English: Tabulated summary of adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
Maltese: Waqt it-tqala fil-far, it-trasferiment ta' 14C-riluzole mis-sekonda għal ġol-fetu kien osservat.
English: Intensive testing in seven other standard in vitro or in vivo assays did not show any genotoxic potential of the metabolite.
Maltese: L-ittestjar intensiv b'seba' metodi oħra, kemm in vitro kif ukoll in vivo, ma wrewx potenzjal ġenotossiku ta' dan il-prodott metaboliku.
English: Pain
Maltese: Lott
English: Package leaflet: Information for the user Riluzole Zentiva 50 mg film-coated tablets riluzole
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' riluzole
English: Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Maltese: Il-pilloli huma taħt għamla ta' kapsuli bojod b' “RPR 202” imnaqqax fuq naħa waħda.
English: Neutropenia
Maltese: Astenja
English: Inhalation use Blister (alu) 3 inhalers (3 x 30 doses) (multipack)
Maltese: 3 inalaturi (3 x 30 doża) (pakkett multiplu)
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA Isem (ivvintat)
English: 5347 JN Oss The Netherlands
Maltese: 5347 JN Oss In-Netherlands
English: † p≤0.001 versus placebo; ‡ p≤0.001 versus etanercept; ¥ p≤0.05 versus etanercept.
Maltese: † p≤0.001 kontra plaċebo; ‡ p≤0.001 kontra etanercept; ¥ p≤0.05 kontra etanercept.
English: Number of patients PASI 75a (%)
Maltese: Numru ta' pazjenti PASI 75a (%)
English: Clinically important active infection, e.g. active tuberculosis (see section 4.4).
Maltese: Infezzjoni attiva klinikament importanti, eż. tuberkulożi attiva (ara sezzjoni 4.4).
English: 2132JH Hoofddorp, Netherlands
Maltese: 2132JH Hoofddorp, In-Netherlands
English: Possible side effects).
Maltese: Effetti sekondarji possibbli).
English: Ronda General Mitre, 151 08022 Barcelona Spain
Maltese: Ronda General Mitre, 151 08022 Barcelona Spanja
English: Ronda General Mitre, 151 08022 Barcelona, Spain
Maltese: Ronda General Mitre, 151 08022 Barcelona, Spanja
English: Week 12 (2 doses)*
Maltese: Ġimgħa 12 (2 dożi)*
English: България/ Česká republika/ Eesti/ Ελλάδα/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/
Maltese: България/ Česká republika/ Eesti/ Ελλάδα/ España/ Hrvatska/
English: Week 28 (3 doses)*
Maltese: Ġimgħa 28 (3 dożi)*
English: DLQI Score 0 or 1 (%)
Maltese: Punteġġ DLQI 0 jew 1 (%)
English: Vistor hf. Sími: +354 535 70 00
Maltese: Sími: +354 535 70 00
English: Ilumetri 200 mg --> Placebo**
Maltese: Ilumetri 200 mg --> Plaċebo**
English: Interactions with cytochrome p450
Maltese: Interazzjonijiet ma' ċitokromu p450
English: 08740 Sant Andreu de la Barca, Barcelona, Spain
Maltese: Sant Andreu de la Barca, Barcelona, Spanja
English: - The active substance is tildrakizumab.
Maltese: - Is-sustanza attiva hi tildrakizumab.
English: List of adverse reactions MedDRA System Organ Class
Maltese: Lista ta' reazzjonijiet avversi Sistema tal-Klassifika talOrgani MedDRA
English: L-Histidine hydrochloride monohydrate Polysorbate 80
Maltese: L-Histidine hydrochloride monohydrate Polisorbat 80
English: Ilumetri 100 mg injection tildrakizumab SC
Maltese: Ilumetri 100 mg injezzjoni tildrakizumab SC
English: Etanercep t
Maltese: Uġigħ ta' ras
English: Tildrakizumab has limited extravascular distribution with volume of distribution (Vd) values ranging from 76.9 to 106 mL/kg.
Maltese: Tildrakizumab għandu distribuzzjoni ekstravaskulari limitata b'valuri tal-volum tad-distribuzzjoni (Vd, volume of distribution) li jvarjaw minn 76.9 sa 106 mL/kg.
English: Patients were 18 to 82 years old, with a mean age of 45.9.
Maltese: Il-pazjenti kellhom 18 sa 82 sena, b'età medjana ta' 45.9.
English: The solution pH is in the range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg.
Maltese: Il-pH tas-soluzzjoni hija fil-medda ta' 5.7 - 6.3 u l-osmolalità hija bejn 258 u 311 mOsm/kg.
English: 200 mg 100 mg Etanercep t reSURFACE1
Maltese: 200 mg 100 mg Plaċebo Etanercept 200 mg 100 mg Etanercept reSURFACE1
English: A total of 1,768 patients were evaluated (705 patients on 100 mg, 708 patients on 200 mg and 355 patients on placebo).
Maltese: Ġew evalwati total ta' 1,768 pazjent (705 pazjenti fuq 100 mg, 708 pazjenti fuq 200 mg u 355 pazjent fuq il-plaċebo).
English: Date of first authorisation: 17 september 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 17 settembru 2018
English: Frequency category
Maltese: Kategorija tal-frekwenza
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2 ºC - 8 ºC).
English: Results from a drug-drug interaction study conducted in plaque psoriasis subjects suggest that tildrakizumab had no clinically relevant effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Maltese: Riżultati minn studju dwar l-interazzjonijiet mediċinali f'individwi bi psorjasi bil-qoxra jissuġġerixxu li tildrakizumab ma kellu l-ebda effett klinikament rilevanti fuq CYP1A2, CYP2C9, CYP2C19, CYP2D6 u CYP3A4.
English: Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Maltese: Ilumetri huwa indikat għall-kura ta' adulti bi psorjasi bil-qoxra moderata sa severa li huma kandidati għal terapija sistemika.
English: 62.3†b 63.8†b
Maltese: 62.3†b 63.8†
English: Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: Tildrakizumab huwa antikorp monoklonali ta' IgG1/k umanizzat prodott f'ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO, Chinese Hamster Ovary) permezz ta' teknoloġija rikombinanti tad-DNA.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC17 Mechanism of action
Maltese: Kategorija farmakoterapewtika Immunosoppressanti, inibituri ta' interleukin, Kodiċi ATC:
English: SUN Pharmaceuticals Industries (Europe) B.V. Polarisavenue 87
Maltese: SUN Pharmaceuticals Industries (Europe) B.V.
English: SUN Pharmaceutical Industries (Europe) B.V. Polarisavenue 87
Maltese: SUN Pharmaceutical Industries (Europe) B.V.
English: Pregnancy, breastfeeding and fertility
Maltese: Tqala, treddigħ u fertilità
English: Adverse reactions (Table 1) are listed by MedDRA system organ class (SOC) 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); and not known (cannot be estimated from available data).
Maltese: Ir-reazzjonijiet avversi (Tabella 1) huma elenkati skont is-sistema tal-klassifika tal-organi (SOC) u lfrekwenza MedDRA, permezz 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); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Of all patients, 35.8% had received prior phototherapy, 41.1% had received prior conventional systemic therapy, 16.7% had received prior biologic therapy for the treatment of plaque psoriasis.
Maltese: Mill-pazjenti kollha, 35.8 % kienu rċivew fototerapija preċedenti, 41.1 % kienu rċivew terapija sistemika konvenzjonali preċedenti, 16.7 % kienu rċivew terapija bijoloġika preċedenti għall-kura tal-psorjasi bil-qoxra.
English: The subcutaneous formulation of tildrakizumab showed an absolute bioavailability ranging from 73% (90% CI: 46% - 115%, 200 mg SC vs. 3 mg/kg IV) to 80% (90% CI: 62% - 103%, 50 mg SC vs. 0.5 mg/kg IV) in healthy subjects, as a result of cross study single dose comparison.
Maltese: Il-formulazzjoni taħt il-ġilda ta' tildrakizumab uriet bijodisponibilità assoluta li varjat minn 73% (90 % CI: 46% - 115%, 200 mg SC vs. 3 mg/kg IV) sa 80% (90% CI: 62% - 103%, 50 mg SC vs. 0.5 mg/kg IV)
English: Mean baseline Dermatology Life Quality Index (DLQI) ranged from 13.0 to 14.8.
Maltese: L-Indiċi tal-Kwalità tal-Ħajja tad-Dermatoloġija (DLQI, Dermatology Life Quality Index) Medju fil-Linja Bażi varja minn 13.0 sa 14.8.
English: This leaflet was last revised in April 2019 Other sources of information
Maltese: Dan il-fuljett kien rivedut l-aħar f'April 2019 Sorsi oħra ta' informazzjoni
English: IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.
Maltese: IL-23 huwa ċitokina li sseħħ b'mod naturali li hija involuta f'risponsi infjammatorji u immuni.
English: The median baseline PASI score ranged from 17.7 to 18.4 across treatment groups.
Maltese: Il-punteġġ PASI medjan fil-linja bażi varja minn 17.7 sa 18.4 fil-gruppi ta' kura.
English: The multicentre, randomised, double-blind, placebo-controlled trials reSURFACE 1 and reSURFACE 2 studies enrolled a total of 1,862 patients 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a Physician Global Assessment (PGA) score of ≥3 in the overall assessment (plaque thickness, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a
Maltese: Il-provi reSURFACE 1 u l-istudji reSURFACE 2 multiċentriċi, randomizzati, double-blind, ikkontrollati bil-plaċebo rreġistraw total ta' 1,862 pazjent ta' età ta' 18-il sena jew ikbar bi psorjasi bil-qoxra li kellhom involviment minimu tal-erja tas-superfiċje tal-ġisem ta' 10 %, punteġġ tal-Valutazzjoni Globali tat-Tobba (PGA, Physician Global Assessment) ta' ≥3 fil-valutazjzoni globali (ħxuna tal-qoxra, eritema u tqaxxir) tal-psorjasi fuq skala tas-severità ta' 0 sa 5, u punteġġ tal-Parti tal-Psorjasi u l-Indiċi tas-Severità (PASI, Psoriasis Area and Severity Index) ta' ≥12, u li kienu kandidati għal fototerapija jew terapija sistemika.
English: EU/1/18/1323/002 2 pre-filled syringes
Maltese: EU/1/18/1323/002 2 siringi mimlijin għal-lest
English: PC: SN:
Maltese: PC:
English: Clearance values range from 2.04 to 2.52 mL/day/kg and the half-life was 23.4 days (23% CV) in subjects with plaque psoriasis.
Maltese: Il-valuri tal-eliminazzjoni jvarjaw minn 2.04 sa 2.52 mL/jum/kg u n-nofs ħajja kienet 23.4 jiem (23% CV) f'individwi bi psorjasi bil-qoxra.
English: Gastrointestinal disorders Gastroenteritis
Maltese: Disturbi gastro-intestinali
English: 200 m g
Maltese: 200 mg
English: Tildrakizumab is a humanized IgG1/k monoclonal antibody that specifically binds to the p19 protein subunit of the interleukin-23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor.
Maltese: Tildrakizumab huwa antikorp monoklonali ta' IgG1/k umanizzat li jorbot speċifikament mas-sottounità tal-proteina p19 taċ-ċitokina interleukin-23 (IL-23) mingħajr ma jeħel ma' IL-12 u li jinibixxi linterazzjoni tagħha mar-riċettur IL-23.
English: At steady state, following administration of 100 mg of tildrakizumab in subjects with moderate to severe plaque psoriasis geometric means (% CV) of AUC0-τ and Cmax values were respectively 305 μg·day/mL (41%) and 8.1 μg/mL (34%), whereas they were 612 μg·day/mL (40%) and 16.3 μg/mL (33%) following administration of 200 mg.
Maltese: Fl-istat fiss, wara għoti ta' 100 mg ta' tildrakizumab f'individwi b'medji ġeometriċi ta' psorjasi bil-qoxra moderata sa severa (% CV) ta' AUC0-τ u l-valuri tas-Cmax kienu rispettivament 305 μg·jum/mL (41%) u 8.1 μg/mL (34%), filwaqt li kienu 612 μg·jum/mL (40%) u 16.3 µg/mL (33%) wara għoti ta' 200 mg.
English: Interactions with other immunosuppressive agents or phototherapy
Maltese: Interazzjonijiet ma' aġenti immunosuppressivi oħrajn jew fototerapija
English: In pooled Phase 2b and Phase 3 analyses 7.3% of Ilumetri-treated patients developed antibodies to Ilumetri.
Maltese: Fl-analiżijiet miġbura ta' Fażi 2b u Fażi 3, 7.3 % tal-pazjenti kkurati b'Ilumetri żviluppaw antikorpi għal Ilumetri.
English: Overall demographic and baseline characteristics in reSURFACE1 and reSURFACE2 studies were consistent across individual trials.
Maltese: Il-karatteristiċi demografiċi u tal-linja bażi globali fl-istudji reSURFACE1 u reSURFACE2 kienu konsistenti fil-provi individwali.
English: The safety and efficacy of Ilumetri in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.
Maltese: Is-sigurtà u l-effikaċja ta' Ilumetri flimkien ma' aġenti immunosuppressivi oħrajn, inkluż bijoloiċi, jew fototerapija ma ġietx evalwata.
English: Following administration of 100 mg or 200 mg of tildrakizumab, subjects who are 65 years or older (n=81 and n=82, respectively) had a similar tildrakizumab clearance as compared to subjects less than 65 years old (n=884).
Maltese: Wara għoti ta' 100 mg jew 200 mg ta' tildrakizumab, individwi li kellhom 65 sena jew aktar (n=81 u n=82, rispettivament) kellhom tneħħija ta' tildrakizumab simili meta mqabbel ma' individwi ta' inqas minn 65 sena (n=884).
English: It is preferable to avoid the use of Ilumetri in pregnancy.
Maltese: Hu preferribbli li ma jintużax Ilumetri waqt it-tqala.
English: Improvements were maintained over time with at week 52, 63.7% (100 mg) and 73.3% (200 mg) in reSURFACE 1, and 68.8% (100 mg) and 72.4% (200 mg) in reSURFACE 2 of patients who were PASI 75 responders at week 28 having a DLQI of 0 or 1.
Maltese: It-titjib inżamm maż-żmien b'sa ġimgħa 52, 63.7% (100 mg) u 73.3 % (200 mg) f'reSURFACE 1, u 68.8% (100 mg) u 72.4 % (200 mg) f'reSURFACE 2 tal-pazjenti li kienu rispondenti għal PASI 75 f'ġimgħa 28 li kellhom DLQI ta' 0 jew 1.
English: Maximum concentration was reached at 6.2 days after injection.
Maltese: Il-konċentrazzjoni massima ntlaħqet wara 6.2 jiem wara l-injezzjoni.
English: Ilumetri has the potential to increase the risk of infection (see section 4.8).
Maltese: Ilumetri għandu l-potenzjal li jżid ir-riskju ta' infezzjoni (ara sezzjoni 4.8).
English: Proportion of Patients with PASI 90 response over time up to Week 64 (Full Analysis Set Part 3*)
Maltese: Wara sa Ġimgħa 64 (Sett ta' Analiżi Sħiħ Parti 3*)
English: Excipients: L-Histidine, L-Histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections.
Maltese: L-Histidine, L-Histidine hydrochloride monohydrate, polysorbate 80, sucrose u ilma għallinjezzjonijiet.
English: Patients randomised to tildrakizumab 100 mg or tildrakizumab 200 mg in Part 1 who were PASI 75 responders at week 28 (reSURFACE1).
Maltese: Pazjenti Randomizzati għal tildrakizumab 100 mg jew tildrakizumab 200 mg f'Parti 1 li rrispondew għal PASI 75 f'Ġimgħa 28 (reSURFACE1).
English: 1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x ½” needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device.
Maltese: Soluzzjoni ta' 1 mL f'siringa mimlija għal-lest tal-ħġieġ tat-tip I b'labra tal-istainless steel 29G x ½”, mgħottija bi protezzjoni tal-labra u protezzjoni tal-labra riġida ta' polypropylene b'laminazzjoni ta' fluropolymer, tapp tal-planġer armat f'apparat tas-sigurtà passiv.
English: Almirall Sp.z o. o. Tel.: +48 22 330 02 57
Maltese: Tel.: +48 22 330 02 57
English: A small air bubble may be apparent: this is normal.
Maltese: Tista' tidher bużżieqa tal-arja żgħira: dan huwa normali.
English: For further information on elimination of tildrakizumab, see section 5.2.
Maltese: Għal aktar informazzjoni dwar l-eliminazzjoni ta' tildrakizumab, ara sezzjoni 5.2
English: Results obtained at weeks 12, 28 and beyond (up to week 64 in reSURFACE 1 and up to week 52 in reSURFACE 2) are presented in Table 2 and Table 3.
Maltese: Ir-riżultati miksubin f'ġimgħat 12, 28 u wara (sa ġimgħa 64 f'reSURFACE 1 u sa ġimgħa 52 f'reSURFACE 2) huma ppreżentati f'Tabella 2 u Tabella 3.
English: Drug interactions
Maltese: Interazzjonijiet mediċinali
English: W4 W8 W12 W16 W22 W28 W32 W36 W40 W44 W48 W52 W56 W60 W64 Ilumetri 100 mg --> Placebo**
Maltese: Ġ4 Ġ8 Ġ12 Ġ16 Ġ22 Ġ28 Ġ32 Ġ36 Ġ40 Ġ44 Ġ48 Ġ52 Ġ56 Ġ60 Ġ64
English: “minimal” with ≥2 grade improvement from Baselinea (%)
Maltese: PGA ta' “tneħħiet” jew “minimali” b'titjib ta' grad ≥2 mil-Linja bażia (%)
English: • Leave the pre-filled syringe in the Ilumetri carton (with the lid closed) and let it sit at room temperature for 30 minutes.
Maltese: • Ħalli s-siringa mimlija għal-lest fil-kartuna ta' Ilumetri (bl-għatu magħluq) u ħalliha toqgħod f'temperatura ambjentali għal 30 minuta.
English: Ilumetri can potentially cause serious side effects, including infections and allergic reactions.
Maltese: Oqgħod attent għal infezzjonijiet u reazzjonijiet allerġiċi Ilumetri jista' potenzjalment jikkawża effetti sekondarji serji, inkluż infezzjonijiet u reazzjonijiet allerġiċi.
English: Maintenance and durability of PASI 90 Response.
Maltese: Proporzjon ta' Pazjenti b'Rispons PASI 90
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Posology
Maltese: PAKKETTI
English: Ilumetri contains the active substance tildrakizumab.
Maltese: Ilumetri fih is-sustanza attiva tildrakizumab.
English: Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Maltese: Tildrakizumab jappartjeni għal grupp ta' mediċini msejħa inibituri ta' interleukin (IL).
English: Prior to initiating treatment with Ilumetri, patients should be evaluated for tuberculosis (TB) infection.
Maltese: Qabel tinbeda kura b'Ilumetri, il-pazjenti għandhom jiġu evalwati għal infezzjoni tat-tuberkulożi (TB).
English: Therefore, tildrakizumab does not impact the pharmacokinetics of concomitant medicines metabolized by CYP enzyme (see section 4.5).
Maltese: Għalhekk, tildrakizumab ma jħallix impatt fuq il-farmakokinetika ta' mediċina konkomitanti li jiġu mmetabolizzati minn enzima CYP (ara sezzjoni 4.5).
English: Nausea
Maltese: Sukrożju