FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving blinatumomab, serious infections, including sepsis, pneumonia, bacteraemia, opportunistic infections and catheter site infections have been observed, some of which were lifethreatening or fatal.
Maltese: F'pazjenti li qed jirċievu blinatumomab, kienu osservati infezzjonijiet serji, li jinkludu sepsi, pulmonite, batterimja, infezzjonijiet opportunistiċi u infezzjonijiet fis-sit tal-kateter, li wħud minn dawn kienu ta' periklu għall-ħajja jew fatali.
English: - The solution (stabiliser) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Maltese: - Is-soluzzjoni (stabbilizzanti) fiha citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide u ilma għall-injezzjonijiet.
English: In paediatric patients, dexamethasone 10 mg/m
Maltese: BLINCYTO sakemm tgħaddi, imbagħad ibda BLINCYTO mill-ġdid b'5 mcg/m2/jum.
English: Infusion catheter
Maltese: Rata tal-infużjoni
English: In an embryo-foetal developmental toxicity study performed in mice, the murine surrogate crossed the placenta to a limited extent (foetal-to-maternal serum concentration ratio < 1%) and did not induce embryo-foetal toxicity or teratogenicity.
Maltese: Fi studju dwar leffett tossiku fuq l-iżvilupp tal-embrijuni u l-feti li twettaq fil-ġrieden, is-sostitut tal-ġrieden għadda mill-plaċenta b'mod limitat (proporzjon ta' konċentrazzjoni fis-serum tal-fetu għall-omm < 1%) u ma induċiex effett tossiku fuq l-embrijuni u l-feti jew teratoġeniċità.
English: Women of childbearing potential have to use effective contraception during and for at least 48 hours after treatment with blinatumomab (see section 4.4).
Maltese: Nisa li li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt it-trattament u tal-anqas għal 48 siegħa wara t-trattament bi blinatumomab (ara sezzjoni 4.4).
English: Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):
Maltese: Kull pakkett ta' BLINCYTO fih kunjett wieħed ta' trab għall-konċentrat għal soluzzjoni għallinfużjoni u kunjett wieħed ta'soluzzjoni (stabilizzanti):
English: 3.3 mL/hour
Maltese: 3.3 mL/siegħa
English: In clinical studies, patients with moderate renal impairment showed an increased incidence of TLS compared with patients with mild renal impairment or normal renal function.
Maltese: Fi studji kliniċi, pazjenti b'indeboliment moderat tal-kliewi wrew żieda fl-inċidenza ta' TLS meta mqabbla ma' pazjenti b'indeboliment ħafif tal-kliewi jew funzjoni normali tal-kliewi.
English: The safety and efficacy of BLINCYTO compared to standard of care (SOC) chemotherapy were evaluated in a randomised, open-label, multicentre, phase III study.
Maltese: Is-sigurtà u l-effikaċja ta' BLINCYTO imqabla ma' kimoterapija ta' kura standard (SOC - standard of care) ġew evalwati fi studju ta' fażi
English: Anti-pyretic use (e.g. paracetamol) is recommended to reduce pyrexia during the first 48 hours of each treatment cycle.
Maltese: L-użu ta' mediċini kontra d-deni (eż. paracetamol) huwa rakkomandat sabiex inaqqas id-deni matul lewwel 48 siegħa ta' kull ċiklu ta' trattament.
English: b. CRh*was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre) and no relapse within 28 days.
Maltese: b. CRh* kienet definita bħala mudullun M1 (≤ 5% ta' blasts fil-mudullun), l-ebda evidenza ta' blasts jiċċirkolaw jew mard ekstramedullari, u rkupru parzjali tal-għadd taċ-ċelluli tad-demm periferali (plejtlits > 50,000/mikrolitru u ANC
English: • flu (influenza)
Maltese: • flu (influwenza)
English: Glutamate Polysorbate 20
Maltese: Polysorbate 20
English: Laboratoires LEO 39 route de Chartres 28500 Vernouillet France
Maltese: Laboratoires LEO 39 route de Chartres 28500
English: The Star Medicines Importers Co. Ltd.
Maltese: The Star Medicines Importers Co.
English: Tinea infections (including tinea pedis, tinea versicolor, tinea cruris)
Maltese: Infezzjonijiet b'tinea (li jinkludu tinea pedis, tinea versicolor, tinea cruris)
English: Immunex Rhode Island Corporation 40 Technology Way, West Greenwich, Rhode Island, 02817
Maltese: Technology Way, West Greenwich, Rhode Island, 02817
English: n-completed Week 52
Maltese: n-kompletat Ġimgħa 52
English: PSI = Psoriasis Symptom Inventory.
Maltese: PSI = Inventarju tas-Sintomu tal-Psorjasi (Psoriasis Symptom Inventory).
English: Table 1: List of adverse reactions in clinical trials System Organ Class
Maltese: Tabella 1: Lista ta' reazzjonijiet avversi fil-provi kliniċi Sistema tal-Klassifika tal-Organi
English: Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Maltese: Infezzjonijiet attivi importanti klinikament attivi (eż. tuberkolożi attiva, ara sezzjoni 4.4). 4.4
English: sPGA 0 or 1 Week 12 sPGA 0 or 1 Week 52
Maltese: sPGA 0 jew 1 Ġimgħa 12 sPGA 0 jew 1 Ġimgħa 52
English: Component of a multipack.
Maltese: Parti minn pakkett multiplu.
English: AMAGINE-2 and AMAGINE-3
Maltese: AMAGINE-2 u AMAGINE-3
English: Arthralgia Myalgia
Maltese: Artralġja Mijalġija
English: Placebo Kyntheum 210 mg Q2W
Maltese: Plaċebo Kyntheum 210 mg Q2W
English: - The active substance is brodalumab.
Maltese: - Is-sustanza attiva hi brodalumab.
English: PASI Baseline score (mean±SD) 19.7±7.7 19.4±6.6 20.2±8.4 20.3±8.3 20.0±8.4 PASI 75 Week 12 (%)
Maltese: PASI Punteġġ Linja bażi (medja±SD) 19.7±7.7 19.4±6.6 20.
English: 4 years
Maltese: 4 snin
English: Important
Maltese: Importanti:
English: 1 ml solution contains 140 mg brodalumab.
Maltese: 1 ml ta' soluzzjoni fih 140 mg brodalumab.
English: Ustekinumab n-randomised n-completed Week 12 n-in maintenance
Maltese: Ustekinumab n-randomizzat n-kompletat Ġimgħa 12
English: • muscle pain.
Maltese: • uġigħ fil-muskoli.
English: PASI 75 Week 52 (%)
Maltese: PASI 75 Ġimgħa 12 (%) PASI 75 Ġimgħa 52 (%)
English: Excipients: proline, glutamate, polysorbate 20 and water for injection.
Maltese: Eċċipjenti: proline, glutamate, polysorbate 20 u ilma għall-injezzjonijiet.
English: Adverse reactions from clinical trials (Table 1) are listed by MedDRA system organ class (SOC).
Maltese: Reazzjonijiet avversi minn provi kliniċi (Tabella 1) huma elenkati skont il-klassifika tas-sistema tal-organi (SOC) MedDRA.
English: Kyntheum 210 mg injection brodalumab
Maltese: Kyntheum 210 mg injezzjoni brodalumab
English: Grade 3 and 4 has been observed occasionally.
Maltese: Grad 3 u 4 ġie osservat okkażjonalment.
English: Baseline static Physician Global Assessment (sPGA) score ranged from “3 (moderate)” (58%) to “5 (very severe)”
Maltese: Il-punteġġ statiku tal-Evalwazzjoni Globali tat-Tabib (sPGA, static Physician Global Assessment) fil-linja bażi varja minn “3 (moderat)” (58%) sa “5 (sever ħafna)” (5%).
English: The percentage of patients that at Week 12 achieved a DLQI (Dermatology Life Quality Index) score of 0 or 1 was 56%, 61%, 59% in the Kyntheum 210 mg group and 5%, 5%, 7% in the placebo group in AMAGINE-1, -2 and -3, respectively (adjusted p-value <0.001) and 44% in the ustekinumab groups (AMAGINE-2 and -3).
Maltese: jew 1, kien ta' 56%, 61%, 59% fil-grupp ta' Kyntheum 210 mg, u 5%, 5%, 7% fil-grupp tal-plaċebo f'AMAGINE-1,-2 u -3, rispettivament (valur p aġġustat ta' < 0.001) u 44% fil-gruppi ta' ustekinumab
English: EU/1/16/1155/002 Multipack containing 6 (3 x 2) pre-filled syringes
Maltese: EU/1/16/1155/002 Pakkett multiplu li fih 6 (3 x 2) siringi mimlija għal-lest
English: Patients enrolled were candidates for systemic therapy, including phototherapy, biologic and nonbiologic systemic therapies.
Maltese: Il-pazjenti rreġistrati kienu kandidati għal terapija sistemika, li tinkludi fototerapija, u terapiji sistemiċi bijoloġiċi u mhux bijoloġiċi.
English: AMAGINE-2 and AMAGINE-3 were identical placebo- and ustekinumab-controlled trials conducted in 1831 and 1881 patients, respectively.
Maltese: AMAGINE-2 u AMAGINE-3 kienu provi identiċi kkontrollati bi plaċebo u b'ustekinumab, li twettqu fuq 1,831 u 1,881 pazjent, rispettivament.
English: PSIBaseline score (mean±SD) PSIresponder Week 12 (%)
Maltese: PSIresponder Ġimgħa 12 (%)
English: Leave the syringe at room temperature for at least 30 minutes before injecting.
Maltese: Ħalli s-siringa fit-temperatura tal-kamra għal mill-inqas 30 minuta qabel tinjetta.
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC12
Maltese: Immunosoppressanti, Inibituri ta' interleukin, Kodiċi ATC:
English: PASI 75 response at 2 weeks ranged between 20% and 25% in the Phase 3 trials compared to placebo (0% to 0.6%) and ustekinumab (3% to 3.5%).
Maltese: Rispons PASI 75 wara ġimagħtejn varja bejn 20% u 25% fil-provi ta' Fażi 3 meta mqabbla mal-plaċebo (0% sa 0.6%) u ustekinumab (3% sa 3.5%).
English: Tel.: +48 22 244 18 40
Maltese: Sp. z o.o. Tel.: +48 22 244 18 40
English: LEO Pharma S.p.A Tel: +39 06 52625500
Maltese: S.p.A Tel: +39 06 52625500
English: Date of first authorisation: 17 July 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Lulju 2017
English: patients being ≥75 years old, within a total PK population of 4271 plaque psoriasis patients.
Maltese: ≥75 sena, fi ħdan popolazzjoni PK totali ta' 4,271 pazjent bi psorjasi tal-plakka.
English: The most commonly reported adverse reactions in all Kyntheum-treated patients were arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi rrappurtati bl-aktar mod komuni fil-pazjenti kollha kkurati b'Kyntheum kienu artralġja (4.6%), uġigħ ta' ras (4.3%), għeja (2.6%), dijarea (2.2%), u wġigħ orofarinġeali (2.1%).
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2°C sa 8°C).
English: • Keep in the refrigerator (2°C to 8°C).
Maltese: • Żommu fil-friġġ (2°C sa 8°C).
English: Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Maltese: Brodalumab hu antikorp monoklonali uman rikombinanti prodott fiċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO).
English: Vistor hf. Sími: +354 535 7000
Maltese: Sími: +354 535 7000
English: Along with primary efficacy endpoints, clinically important improvements were observed in Psoriasis Scalp Severity Index (PSSI) at Week 12 (AMAGINE-1) and in Nail Psoriasis Severity Index (NAPSI) at Week 12 and 52 (AMAGINE-1,-2, and -3).
Maltese: (AMAGINE-1), u fl-Indiċi tas-Severità ta' Psorjasi fid-Dwiefer (NAPSI, Nail Psoriasis Severity Index) f'Ġimgħa 12 u 52 (AMAGINE-1,-2, u -3).
English: Q2W = every 2 weeks
Maltese: Q2W = kull ġimagħtejn
English: AMAGINE-1 was conducted in 661 patients.
Maltese: AMAGINE-1 twettaq f'661 pazjent.
English: In addition, the corresponding frequency category for each adverse reaction is based on 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) and very rare (<1/10,000).
Maltese: Ukoll, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa, hi bbażata fuq il-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) u rari ħafna (<1/10,000).
English: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
Maltese: LEO Pharma A/S Industriparken 55
English: The subcutaneous bioavailability of brodalumab estimated by population pharmacokinetic modelling was 54.7% (relative standard error [RSE] = 4.25%).
Maltese: relative standard error] = 4.25%).
English: IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes.
Maltese: IL-17C iwassal għal risponsi simili bħal ta' IL-17A u IL-17F fil-keratanocytes.
English: No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
Maltese: L-ebda evidenza ta' profil farmakokinetiku alterat, rispons kliniku, jew profil ta' sigurtà, ma kienet assoċjata ma' żvilupp ta' antikorpi kontra brodalumab.
English: Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity.
Maltese: Dożi sa 700 mg ġol-vini ingħataw fil-provi kliniċi mingħajr ebda evidenza ta' tossiċità li tillimita d-doża.
English: AMAGINE-2 and AMAGINE-3 were also active comparator (ustekinumab)-controlled.
Maltese: AMAGINE-2 u AMAGINE-3 kienu wkoll ikkontrollati minn komparatur attiv (ustekinumab).
English: Antibodies to brodalumab developed in 2.7% (122/4461) of patients treated with Kyntheum for up to 52 weeks in psoriasis clinical trials (0.3% of these patients had anti-brodalumab antibodies at baseline).
Maltese: Immunoġeniċità Antikorpi għal brodalumab żviluppaw fi 2.7% (122/4,461) tal-pazjenti kkurati b'Kyntheum għal sa 52 ġimgħa fil-provi kliniċi dwar il-psorjasi (0.3% ta' dawn il-pazjenti kellhom antikorpi kontra brodalumab fil-linja bażi).
English: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution (140 mg/1 ml).
Maltese: Kull siringa mimlija għal-lest fiha 210 mg brodalumab f'1.5 ml soluzzjoni (140 mg/1 ml).
English: *p-value vs. corresponding placebo, adjusted for stratification factors <0.001
Maltese: *il-valur-p vs. plaċebo korrespondenti, aġġustat għal fatturi ta' stratifikazzjoni <0.
English: IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of proinflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation.
Maltese: IL-17A, IL-17F u IL-17A/F heterodimer għandhom attivitajiet plejotropiċi, li jinkludu l-induzzjoni ta' medjaturi proinfjammatorji bħal IL-6, GROα, u G-CSF minn ċelluli epiteljali, ċelluli endoteljali u fibroblasti li jippromwovu l-infjammazzjoni tat-tessut.
English: In a local tolerance test in rabbits, moderate to severe edema was observed after subcutaneous injection of a formulation containing brodalumab at the clinical concentration of 140 mg/ml.
Maltese: F'test ta' tolleranza lokali fil-fniek, ġiet osservata edema moderata sa severa wara injezzjoni taħt il-ġilda tal-formulazzjoni li fiha brodalumab, f'konċentrazzjoni klinika ta' 140 mg/ml.
English: EU/1/16/1155/001 Pack containing 2 pre-filled syringes
Maltese: EU/1/16/1155/001 Pakkett li fih 2 siringi mimlija għal-lest
English: As an IgG2 human monoclonal antibody brodalumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Maltese: Bħala antikorp monoklonali uman IgG2, brodalumab hu mistenni li jiġi ddegradat f'peptides żgħar u amino acids permezz ta' passaġġi kataboliċi b'mod simili għal IgG endoġenu.
English: However, brodalumab concentrations below LLOQ (Lower Limit of Quantification) were associated with IL-17 receptor occupancy up to 81%.
Maltese: Madankollu, il-konċentrazzjonijiet ta' brodalumab taħt LLOQ (Lower Limit of Quantification, limitu aktar baxx ta' kwantifikazzjoni) kienu assoċjati ma' okkupanza ta' riċettur ta' IL-17 sa 81%.
English: Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors.
Maltese: Brodalumab jappartieni għal grupp ta' mediċini msejħa inibituri ta' interleukin (IL).
English: In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%.
Maltese: brodalumab, żiedet l-esponiment ta' midazolam, substrat ta' CYP3A4/3A5, b'24%.
English: Kyntheum is a medicine that contains the active substance brodalumab.
Maltese: Kyntheum hu mediċina li fiha is-sustanza attiva brodalumab.
English: Oropharyngeal pain
Maltese: Labra użata
English: Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Kyntheum huwa indikat għall-kura ta' psorjasi tal-plakka minn moderata sa severa f'pazjenti adulti li huma kandidati għal terapija sistemika.
English: One serious case of cryptococcal meningitis and one serious case of coccidioidies infection were observed in clinical trials (see section 4.4).
Maltese: Kien hemm każ serju wieħed ta' meninġite kriptokokkali u każ wieħed serju ta' infezzjoni coccidioidies ġew osservati fil-provi kliniċi (ara sezzjoni 4.4).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INLCUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA TA' PAKKETT MULTIPLU (INKLUŻ KAXXA BLU)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Population pharmacokinetic modelling indicated that age did not have an effect on brodalumab pharmacokinetics, which was co-based on 259 (6%) patients being 65-74 years old and on 14 (0.3%)
Maltese: Mudellar farmakokinetiku tal-popolazzjoni indika li l-età ma kellhiex effett fuq il-farmakokinetika ta' brodalumab, li kien ko-bbażat fuq 259 pazjent (6%) ta' bejn 65-74 sena u fuq 14-il pazjent (0.3%)
English: PSI responder: total score ≤8 with no item scores >1; SD: standard deviation.
Maltese: mingħajr ebda punteġġ tal-oġġett >1; SD: devjazzjoni standard.
English: The observed pharmacokinetic parameters during steady-state (weeks 10-12) were: mean steady-state area under the concentration time curve over the dosing interval (AUCtau) was 227.4 mcg*day/ml (SD = 191.7 mcg*day/ml) corresponding to average concentration (Cav,ss) of 16.2 mcg/ml, mean Cmax was 20.9 mcg/ml (SD = 17.0 mcg/ml) and Week 12 mean minimum serum concentration (Ctrough) was 9.8 mcg/ml (SD = 11.2 mcg/ml).
Maltese: Il-parametri farmakokinetiċi osservati matul l-istat stabbli (ġimgħat 10-12) kienu: il-medja fl-istat tal-erja taħt il-kurva konċentrazzjoni-żmien matul l-intervall tad-dożaġġ (AUCtau) li kienet ta' 227.4 mcg*jum/ml (SD = 191.7 mcg*jum/ml) li tikkorrispondi għal konċentrazzjoni medja (Cav,ss) ta' 16.2 mcg/ml, il-medja tas-Cmax kienet 20.
English: Elevated levels of expression of IL-12B and IL-23A, the genes for the two subunits of IL-23, an upstream activator of IL-17A and IL-17F expression, are also found in psoriatic plaques.
Maltese: Livelli għoljin tal-espressjoni ta' IL-12B u IL-23A, il-ġeni għaż-żewġ sottounitajiet ta' IL-23, attivatur upstream ta' IL-17A u espressjoni
English: Pharmacokinetic/pharmacodynamic relationship(s) A population pharmacokinetic/pharmacodynamic model, developed using all available data indicated that at a dose of 210 mg every 2 weeks, 90% of all patients would be predicted to maintain a trough concentration greater than the estimated IC90 value of 1.51 mcg/ml.
Maltese: Mudell farmakokinetiku/farmakodinamiku tal-popolazzjoni, żviluppat bl-użu tad-dejta kollha disponibbli, indika li f'doża ta' 210 mg kull ġimagħtejn, 90% tal-pazjenti kollha huma mbassra li se jżommu konċentrazzjoni minima akbar mill-valur IC90 stmat ta' 1.51 mcg/ml.
English: Possible serious infections (may affect up to 1 in 100 people), the signs may include:
Maltese: Possibbiltà ta' infezzjoni serja (jistgħu jaffettwaw sa 1 persuna minn kull 100), is-sinjali jistgħu jinkludu:
English: In moderate to severe plaque psoriasis patients following a single subcutaneous administration of Kyntheum at 210 mg, the mean maximum serum concentration (Cmax) was 13.4 mcg/ml (standard deviation [SD] = 7.29 mcg/ml).
Maltese: F'pazjenti bi psorjasi tal-plakka minn moderata sa severa, wara għoti wieħed taħt il-ġilda ta' Kyntheum f'doża ta' 210 mg, il-medja tal-konċentrazzjoni massima fis-serum (Cmax) kienet 13.4 mcg/ml (devjazzjoni standard [SD] = 7.29 mcg/ml).
English: In all three clinical trials, examination of age, gender, race, use of prior systemic or photo therapy, use of prior biologics, and biologic failures did not identify differences in response in all key endpoints [PASI 75, PASI 100, sPGA success (0 or 1), and sPGA clear (0)] to Kyntheum among these subgroups.
Maltese: Fit-tliet provi kliniċi kollha, eżami tal-età, sess tal-persuna, razza, l-użu ta' terapija sistemika jew fototerapija fil-passat, l-użu ta' terapija bijoloġika, u fallimenti ta' terapija bijoloġika, ma identifikawx differenzi fir-rispons fil-punti aħħarin ewlenin kollha [PASI 75, PASI 100, suċċess sPGA (0 jew 1), u xejn sPGA (0)] għal Kyntheum fost dawn is-sottogruppi.
English: LEO Pharma AB Tlf: +45 70 22 49 11
Maltese: Tlf: +45 70 22 49 11
English: LEO Pharma GmbH
Maltese: LEO Pharma
English: Uncommon Candida infections (including oral, genital, and oesophageal infections)
Maltese: Infezzjonijiet b'candida (li jinkludu infezzjonijiet orali, ġenitali, u esofageali)
English: The median time to maximum concentration (Tmax) was 3.0 days (range: 2.0 to 4.0 days) and the mean area under the concentration time curve to the last measurable concentration (AUClast) was 111 mcg*day/ml (SD = 64.4 mcg*day/ml).
Maltese: Iż-żmien medjan għall-konċentrazzjoni massima (Tmax) kien 3.0 ijiem (medda: 2.0 sa 4.0 jiem) u l-medja tal-erja taħt il-kurva konċentrazzjoni-żmien sal-aħħar konċnetrazzjoni li setgħet titkejjel (AUClast) kienet ta' 111 mcg*jum/ml (SD = 64.4 mcg*jum/ml).
English: Although a role for interleukin (IL)-17A and IL-17RA in the regulation of CYP450 enzymes has not been reported, the effect of brodalumab on CYP3A4/3A5 activity was evaluated in a disease-drug-drug interaction study.
Maltese: IL-17RA fir-regolazzjoni tal-enzimi CYP450 ma ġiex irrappurtat, l-effett ta' brodalumab fuq l-attività ta' CYP3A4/3A5 ġie evalwat fi studju ta' interazzjoni fil-mard u bejn mediċina u oħra.
English: Elevated levels of IL-17A, IL-17C and IL-17F gene expression are found in psoriatic plaques.
Maltese: Livelli għoljin ta' IL-17A, IL-17C u l-espressjoni tal-ġeni ta' IL-17F jinsabu fi plakek psorjatiċi.
English: During the 12-week placebo-controlled clinical trial period in patients with psoriasis, serious infections were observed in 0.5% of patients receiving Kyntheum (see section 4.8).
Maltese: Matul il-perjodu tal-prova klinika kkontrollata bi plaċebo li dam 12-ġimgħa f'pazjenti bi psorjasi, ġew osservati infezzjonijiet serji f'0.5% tal-pazjenti li kienu qed jirċievu Kyntheum (ara sezzjoni 4.8).
English: Neutropenia Grade 3 and 4 were reported in 0.4% of patients receiving Kyntheum compared to 0.2% of patients who received ustekinumab and none in patients receiving placebo.
Maltese: Newtropenija ta' Grad 3 u 4 ġiet irrappurtata f'0.4% tal-pazjenti li kienu qed jirċievu Kyntheum meta mqabbla ma' 0.2% tal-pazjenti li rċivew ustekinumab u ħadd mill-pazjenti li kienu qed jirċievu plaċebo.
English: Other medicines and Kyntheum
Maltese: Mediċini oħra u Kyntheum
English: Non-responder imputation is used to impute missing data.
Maltese: Imputazzjoni non-responder tintuża biex timputa data nieqsa.
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 għall-Mediċini: http://www.ema.europa.eu.
English: IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.
Maltese: IL-17RA hi proteina espressa fuq il-wiċċ taċ-ċelluli u hu komponent meħtieġ ta' kumplessi tar-riċetturi użati minn cytokines multipli tal-familja IL-17.
English: Both trials included a 12-week double-blind, placebo- and ustekinumab-controlled induction phase followed by a double-blind maintenance phase up to 52 weeks.
Maltese: Il-prova inkludiet fażi ta' induzzjoni ta' 12-il ġimgħa double-blind, ikkontrollata bi plaċebo, segwita minn fażi double-blind ta' twaqqif tal-mediċina u kura mill-ġdid li damet sa 52 ġimgħa.
English: Approximately 21% of patients had a history of psoriatic arthritis.
Maltese: Madwar 21% tal-pazjenti kellhom storja medika ta' artrite psorjatika.