FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections occurred in 13 (0.6 %) of patients treated with Taltz and in 3 (0.4 %) of patients treated with placebo (see section 4.4).
Maltese: (0.6%) mill-pazjenti ttrattati b'Taltz u f'3 (0.4%) mill-pazjenti ttrattati bil-plaċebo (ara sezzjoni 4.4).
English: A total of 7,339 patients have been treated with Taltz in blinded and open-label clinical studies in plaque psoriasis, psoriatic arthritis, and other autoimmune conditions.
Maltese: Total ta' 7,339 pazjent ġew ittrattati b'Taltz fi studji kliniċi open-label u blinded bi psorjasi bil-plakka,
English: Exposure (AUC) increased proportionally over a dose range of 5 to 160 mg given as a subcutaneous injection.
Maltese: L-esponiment (AUC) żdied b'mod proporzjonali fuq il-medda ta' dożi minn 5 sa 160 mg mogħtija bħala injezzjoni taħt il-ġilda.
English: Plaque psoriasis
Maltese: Psorjasi bil-plakka
English: Taltz-treated patients reported improvements in health-related quality of life as measured by the Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p<0.001).
Maltese: Il-pazjenti ttrattati b'Taltz irrapportaw titjib fil-kwalità tal-ħajja fir-rigward ta' saħħa kif evalwat mill-punteġġ tal-Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS)
English: EU/1/15/1085/004 EU/1/15/1085/005 EU/1/15/1085/006
Maltese: EU/1/15/1085/005 EU/1/15/1085/006
English: Of the 3,866 patients enrolled in these placebo-controlled studies, 64 % had received prior systemic therapy (biologic, conventional systemic or psoralen and ultraviolet A (PUVA)), 43.5 % had received prior phototherapy, 49.3 % had received prior conventional systemic therapy, and 26.4 % had received prior biologic therapy for the treatment of psoriasis.
Maltese: Mit-3,866 pazjent li ġew irreġistrati f'dawn l-istudji kkontrollati bi plaċebo, 64% kienu rċivew terapija sistemika qabel (bijoloġika, sistemika konvenzjonali jew psoralen u ultravjola A (PUVA - psoralen and ultraviolet A)), 43.5% kienu rċivew fototerapija qabel, 49.3% kienu rċivew terapija sistemika konvenzjonali qabel, u 26.
English: ACR 70 response, n (%) Week 24
Maltese: Rispons ACR 70, n (%)
English: ACR 20 response, n (%) Week 24
Maltese: Rispons ACR 20, n (%)
English: PASI-Response Rates from comparative study ixekizumab versus ustekinumab
Maltese: Rati ta' Rispons-PASI minn studju komparattiv ixekizumab kontra ustekinumab
English: Laboratory assessment of neutropenia and thrombocytopenia In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia.
Maltese: Valutazzjoni fil-laboratorju ta' newtropenija u tromboċitopenija Fl-istudji tal-psorjasi bil-plakka, 9% mill-pazjenti li kienu qed jirċievu Taltz żviluppaw newtropenija.
English: Efficacy results in SPIRIT-P1 and SPIRIT-P2 at week 24
Maltese: Riżultati ta' effikaċja f'SPIRIT-P1 u SPIRIT-P2 fl-24 ġimgħa
English: This medicine is for single use only.
Maltese: Il-mediċina li qegħda ġewwa għandha tkun ċara.
English: The mean (SD) maximum plasma concentration (Cmax) of ixekizumab, after the 160 mg starting dose, was 19.9 (8.15) µg/ml.
Maltese: tal-ogħla konċentrazzjoni ta' ixekizumab fil-plażma (Cmax), wara d-doża tal-bidu ta' 160 mg, kienet 19.9 (8.15) µg/ml.
English: - runny nose.
Maltese: - ħorriqija.
English: Onset of response was superior on PASI 75 as early as week 2 (p < 0.001) and on PASI 90 and PASI 100 by week 4 (p < 0.001).
Maltese: Iż-żmien għar-rispons kien superjuri fuq PASI 75 minn kmieni minn ġimgħa 2 (p < 0.001) u fuq PASI 90 u PASI 100 minn ġimgħa 4 (p < 0.001).
English: Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years of age or older and 36 patients were 75 years of age or older.
Maltese: Mill-4,204 pazjenti bi psorjasi bil-plakka esposti għal Taltz fi studji kliniċi, total ta' 301 kellhom età ta' 65 sena jew aktar u 36 pazjent kellhom età ta' 75 sena jew aktar.
English: Of the 1,118 psoriatic arthritis patients exposed to Taltz in clinical studies, a total of 122 patients were 65 years of age or older and 6 patients were 75 years of age or older.
Maltese: Mill-1,118-il pazjent b'artrite psorjatika esposti għal Taltz fi studji kliniċi, total ta' 122 pazjent kellhom età ta' 65 sena jew aktar u 6 pazjenti kellhom età ta' 75 sena jew aktar.
English: Across studies, Taltz was associated with statistically significant improvement of itching severity assessed by the Itch NRS score.
Maltese: studji, Taltz kien assoċjat ma' titjib statistikament sinifikanti fis-severità tal-ħakk, kif ivvalutat mill punteġġ Itch NRS.
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 wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: sPGA of “0” or “1” is equivalent to “clear” or “minimal”; NRS = Numeric Rating Scale
Maltese: NRS = Skala ta' Valur Numeriku (Numeric Rating Scale);
English: Taltz reduces the signs and symptoms of the disease.
Maltese: Taltz inaqqas is-sinjali u s-sintomi tal-marda.
English: The efficacy and safety of Taltz were assessed in three randomised, double-blind, placebo-controlled phase III studies in adult patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy (UNCOVER-1, UNCOVER-2, and UNCOVER-3).
Maltese: III ikkontrollati bi plaċebo fejn la l-investigaturi u lanqas l-individwi li ntgħażlu b'mod arbitrarju ma kienu jafu liema sustanza qegħda tintuża f'pazjenti adulti bi psorjasi bil-plakka minn moderata sa severa u li kienu kandidati għal fototerapija jew terapija sistemika (UNCOVER-1, UNCOVER-2, u UNCOVER-3).
English: 3 FINISH 3a
Maltese: 3a
English: Psoriatic Arthritis Study 2 (SPIRIT-P2) enrolled patients who were previously treated with an anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance (anti-TNF-IR patients).
Maltese: L-Istudju 2 ta' Artrite Psorjatika (SPIRIT-P2), ġabar pazjenti li preċedentement kienu kkurati b'sustanza anti-TNF u waqfu s-sustanza anti-TNF jew minħabba nuqqas ta' effikaċja jew minħabba intolleranza (pazjenti anti-TNF-IR).
English: Patients had at least moderate plaque psoriasis (defined as sPGA score of ≥ 3 and being candidates for phototherapy and/or systemic therapy) for at least 6 months.
Maltese: Il-pazjenti kellhom mill-inqas psorjasi tal-plakka moderata ( definita bħala punteġġ sPGA ta' ≥ 3 u li huma kandidati għall-fototerapija u/jew terapija sistemika) għal mill inqas 6 xhur.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Taltz
English: ** Taltz 160 mg Week 0, then 80 mg every 2 weeks to Week 12 and every 4 weeks thereafter for patients with moderate to severe plaque psoriasis or 160 mg Week 0, then 80 mg every 4 week for other patients, ADA 80 mg Week 0, then 40 mg every 2 weeks from Week 1 for patients with moderate to severe plaque psoriasis or 40 mg Week 0, then 40 mg every 2 weeks for other patients.
Maltese: ** Taltz 160 mg Ġimgħa 0, imbagħad 80 mg kull ġimagħtejn sa Ġimgħa 12 u minn hemm 'il quddiem kull 4 ġimgħat għal pazjenti b'psorjasi moderata għal severa jew 160 mg Ġimgħa 0, imbagħad 80 mg kull 4 ġimgħat għal pazjenti oħra, ADA 80 mg Ġimgħa 0, imbagħad 40 mg kull ġimagħtejn minn Ġimgħa 1 għal pazjenti bi psorjasi bil-plakka moderata għal severa jew 40 mg Ġimgħa 0, imbagħad 40 mg kull ġimagħtejn għal pazjenti oħra.
English: STATEMENT OF ACTIVE SUBTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: ACR 50 response, n (%) Week 24
Maltese: Rispons ACR 50, n (%)
English: 80 mg Q2W (induction) / 80 mg Q4W (maintenance) (N = 221)
Maltese: 80 mg Q2W (fil-bidu) / 80 mg Q4W (manteniment) (N = 221)
English: The proportion of patients achieving a PASI 75, PASI 90, and PASI 100 response at Week 24 was greater with Taltz Q4W compared to placebo (p<0.001).
Maltese: In-numru ta' pazjenti li kisbu rispons ta' PASI 75, PASI 90, u PASI 100 fl24 Ġimgħa kien akbar b'Taltz Q4W meta mqabbel ma' plaċebo (p<0.001).
English: Treatment with Taltz is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections (see section 4.8).
Maltese: It-trattament b'Taltz huwa assoċjat ma' żieda fir-rata ta' infezzjonijiet bħal infezzjoni fin-naħa ta' fuq tal-apprat tan-nifs, kandidjasi orali, konġuntivite, u infezzjonijiet b'tinea (ara sezzjoni 4.8).
English: In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz.
Maltese: Fiż-żewġ studji kliniċi li kienu jinkludu kumparatur attiv (UNCOVER-2 u UNCOVER-3), ir-rata ta' każijiet avversi serji kienet 1.9% kemm għal etanercept kif ukoll għal Taltz, u r-rata ta' waqfien minħabba każijiet avversi kienet 1.2% għal etanercept u 2.0% għal Taltz.
English: - After the first dose, you will use an 80 mg dose (one injection) at Weeks 2, 4, 6, 8, 10, and 12.
Maltese: - Wara l-ewwel doża, inti se tuża doża ta' 80 mg (injezzjoni waħda) fil-Ġimgħat 2, 4, 6, 8, 10, u 12.
English: The primary endpoint was the proportion of patients who achieved at least a "0" (clear) or "1" (minimal) response on the sPGA of Genitalia (sPGA of Genitalia 0/1).
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti li kisbu rispons ta' mill-inqas "0" (ċara) jew "1" (minimu) fl-sPGA tal-Ġenitalja (sPGA tal-Ġenitalja 0/1).
English: Figure 3: Primary Endpoint (Simultaneous ACR 50 & PASI 100) and Major Secondary Endpoints (ACR 50; PASI 100) Response Rates Week 0 - 24 [ITT population, NRI]**
Maltese: Figura 3: Punt Finali Primarju (ACR 50 &
English: Mean (SD) Cmax,ss, and Ctrough,ss estimates are 14.6 (6.04) µg/ml, and 1.87 (1.30) µg/ml.
Maltese: (6.04) µg/ml, u 1.87 (1.30) µg/ml.
English: From population pharmacokinetic analyses, the mean total volume of distribution at steady state was 7.11 L.
Maltese: Minn diversi analiżi ta' farmakokinetika ta' popolazzjoni, il-medja tat-total tal-volum ta' distribuzzjoni fl-istat fiss kienet 7.11 L.
English: Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1).
Maltese: Taltz, waħdu jew flimkien ma' methotrexate, huwa indikat għat-trattament ta' artrite psorjatika attiva f'pazjenti adulti li ma rrispondewx sew jew ma jittollerawx wieħed jew iżjed mit-terapiji ta' mediċini antirewmatiċi li jimmodifikaw il-mard (DMARD) ( ara sezzjoni 5.1).
English: The percentage of patients with no radiographic joint damage progression from randomisation to Week 52 was 90.9% for placebo/Taltz Q4W, 85.6% for Taltz Q4W/Taltz Q4W, and 89.4% for adalimumab/Taltz Q4W.
Maltese: 6% għal Taltz Q4W/Taltz Q4W, u 89.4% għal adalimumab/Taltz Q4W.
English: Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and PASI 100 response at Week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 15.8%]).
Maltese: Taltz kien superjuri għal ADA fl-għan primarju tal-istudju: il-ksib simultanju ta' rispons ta' ACR 50 u PASI 100 fl-24 Ġimgħa (Taltz 36.0% vs ADA 27.9%; p=0.036; intervall ta' kunfidenza ta' 95%
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA/I BIOLOĠIKA ATTIVA U MANIFATTUR
English: This medicine works by neutralising the activity of a protein called IL-17A, which promotes psoriasis and psoriatic arthritis.
Maltese: Din ilmediċina taħdem billi tinnewtralizza l-attività ta' proteina msejħa IL-17A, li tinkoraġġixxi l psorjasi u l-artrite psorjatika..
English: ACR 20 response in SPIRIT-P1 over time up to Week 24
Maltese: Ir-rispons tal-ACR 20 f'SPIRIT-P1 maż-żmien sal-24
English: For both studies, the primary endpoint was American College of Rheumatology (ACR) 20 response at Week 24.
Maltese: Għażżewġ studji, il-punt finali primarju kien ir-rispons tal-American College of Rheumatology (ACR) 20 fl-24 Ġimgħa.
English: Insert the needle at a 45-degree angle.
Maltese: Daħħal il-labra f'angolu ta' 45 grad.
English: “1” (rarely limited) a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no effect at all on patient's life.
Maltese: NRI = Implikazzjoni li ma kienx hemm rispons (Non-Responder Imputation); sPGA = Evalwazzjoni Globali statika mill-ispeċjalista (static Physician Global Assessment); GPSS = Skala ta' Sintomi ta' Psorjasi Ġenitali (Genital Psoriasis Symptom Scale);
English: The safety and efficacy of Taltz were assessed in two randomised, double-blind, placebo-controlled phase III studies in 780 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints).
Maltese: double-blind u magħmula b'mod arbitrarju, f'780 pazjent b'artrite psorjatika attiva (≥3 ġogi minfuħin u ≥3 ġogi sensittivi).
English: Over 58.9% and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively.
Maltese: u 22.3% tal-pazjenti b'artrite psorjatika kellhom entesite u daktilite fil-linja bażi, rispettivament.
English: Patients in all treatment groups had a median baseline PASI score ranging from 17.4 to 18.3; 48.3 % to 51.2 % of patients had a baseline sPGA score of severe or very severe, and mean baseline itch Numeric Rating Scale (itch NRS) ranging from 6.3 to 7.1.
Maltese: Il-pazjenti fil-gruppi kollha ta' trattament kellhom linja bażi medjana ta' punteġġ ta' PASI li tvarja minn 17.4 sa 18.3; 48.3% sa 51.2% tal pazjenti kellhom linja bażi ta' punteġġ ta' sPGA ta' sever jew sever ħafna, u linja bażi medja ta' ħakk fuq l-Iskala ta' Klassifikazzjoni Numerika (itch NRS - itch Numeric Rating Scale) li tvarja minn 6.3 sa
English: Results from a drug-drug interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with drugs metabolized by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these drugs.
Maltese: midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) jew
English: The mean elimination half-life, as estimated from population pharmacokinetic analysis, is 13 days in patients with plaque psoriasis.
Maltese: Il-medja tal-half life ta' eliminazzjoni, kif stmat minn analiżi farmakokinetika tal-popolazzjoni, hija ta' 13-il jum f'pazjenti bi psorjasi bil-plakka.
English: At Week 52, the mean change from baseline in mTSS was 0.27 for placebo/Taltz Q4W, 0.54 for Taltz Q4W/Taltz Q4W, and 0.32 for adalimumab/Taltz Q4W.
Maltese: Fit-52 Ġimgħa, il-bidla medja mil-linja bażi f'mTSS kien ta' 0.27 għal plaċebo/Taltz Q4W, 0.54 għal Taltz Q4W/Taltz Q4W, u 0.
English: Patients in these studies had a diagnosis of psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 5.33 years.
Maltese: Pazjenti f'dawn l-istudji kellhom dijanjosi ta' artrite psorjatika (Klassifikazzjoni ta' Kriterja għall-Artrite Psorjatika-Classification Criteria for Psoriatic Arthritis [CASPAR] ) għal medjan ta' 5.33 snin.
English: Gray syringe plunger
Maltese: Planġer griż tas-siringa
English: Ixekizumab is a recombinant humanised monoclonal antibody produced in CHO cells.
Maltese: Ixekizumab huwa antikorp monoklonali rikombinanti umanizzat magħmul fiċ-ċelluli ta' CHO.
English: 80 mg Q4W (induction) / 80 mg Q4W (maintenance)
Maltese: 80 mg Q4W (fil-bidu) / 80 mg Q4W (manteniment)
English: • It is past the expiry date.
Maltese: • Qabżet id-data ta' skadenza.
English: In the population PK analysis, mean serum clearance was 0.0161 L/hr.
Maltese: Fl-analiżi PK tal-popolazzjoni, il-medja tat-tneħħija mis-serum kienet 0.0161 L/siegħa.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b Patients with Itch NRS >= 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
Maltese: a p < 0.001 imqabbel ma' plaċebo b Il-pazjenti b'NRS ta' ħakk ta' >= 4 fil-linja bażi: plaċebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
English: Number of patients (N) randomized
Maltese: Pazjenti (n)
English: 80 mg Q2W (induction) / 80 mg Q4W (maintenance)
Maltese: 80 mg Q2W (fil-bidu) / 80 mg Q4W (manteniment)
English: sPGA of “0” (clear) or “1” (minimal)
Maltese: jew “1” (minima)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih inqas minn mmol 1 ta' sodium (23 mg) f'kull doża ta' 80 mg, i.e., huwa essenzjalment “ħieles mis-sodium”.
English: Of all patients, 14.9 % had received at least one anti-TNF alpha agent, and 8.7 % had received an anti-IL-12/IL-23.
Maltese: Millpazjenti kollha, 14.9% kienu rċivew mill-anqas sustanza waħda kontra TNF alpha, u 8.7% kienu rċivew sustanza kontra
English: Neutropeniag, Thrombocytopeniag
Maltese: Il-parti prinċipali tas-siringa bil mediċina
English: Pack sizes of 1, 2, 3 pre-filled syringes.
Maltese: Daqsijiet tal-pakkett ta' 1, 2, 3 siringi mimlijin għal-lest.
English: Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of ixekizumab have not been conducted.
Maltese: Ma sarux studji farmakoloġiċi kliniċi speċifiċi biex jistmaw l-effetti ta' indeboliment tal-kliewi u indeboliment tal-fwied fuq il-PK ta' ixekizumab.
English: This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodiumfree”.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodium (23 mg) f'kull doża ta' 80 mg, i.e., huwa essenzjalment “ħieles mis-sodium”.
English: Ixekizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Maltese: Ixekizumab jagħmel parti minn grupp ta' mediċini msejħa inibituri ta' interleukin (IL).
English: The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, disease duration, baseline body weight, baseline psoriasis involvement, baseline CRP, baseline DAS28-CRP, concomitant corticosteroid use, and previous treatment with a biologic.
Maltese: L-effikaċja u s-sigurtà ta' Taltz ġew murija irrispettivament mill-età, sess, razza, kemm ilha l-marda, piż tal-ġisem fil-linja bażi, l-ammont ta' psorjasi fil-linja bażi, CRP fil-linja bażi, DAS28-CRP fil-linja bażi, l-użu fl-istess ħin ta' kortikosterojdi, u trattament preċedenti b'sustanza bijoloġika.
English: Ixekizumab is a monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous immunoglobulins.
Maltese: Ixekizumab huwa antikorp monoklonali u huwa mistenni li jitkisser f'peptidi żgħar u aċidi amminiċi permezz ta' sensiela ta' reazzjonijiet kataboliċi bl-istess mod bħal immunoglobini endoġeni.
English: The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in either the plaque psoriasis or the psoriatic arthritis studies g Based on reported adverse events h Based on postmarketing reports i Adverse drug reactions in patients treated with ixekizumab in the plaque psoriasis and psoriatic arthritis clinical trials were similar with the exception of the frequencies of influenza (common) and conjunctivitis (common) in the psoriatic arthritis clinical trials
Maltese: gIbbażati fuq avvenimenti avversi rrapportati hIbbażati fuq rapporti wara t-tqegħid fis-suq iIr-reazzjonijiet avversi għall-mediċina f'pazjenti ttrattati b'ixekizumab kienu simili kemm fil-provi kliniċi tal-psorjasi bil-plakka u kemm fil-provi kliniċi tal-artrite psorjatika bl-eċċezzjoni tal-frekwenzi tal-influwenza (komuni) u tal-konġuntivite (komuni) fil-provi kliniċi tal-artrite psorjatika.
English: Taltz 80 mg injection ixekizumab Subcutaneous use
Maltese: Taltz 80 mg soluzzjoni għall-injezzjoni ixekizumab
English: In Psoriatic Arthritis Study 1 (SPIRIT-P1), patients naive to biologic therapy with active psoriatic arthritis were randomised to subcutaneous injections of placebo, adalimumab 40 mg once every 2 weeks (active control reference arm), Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
Maltese: Fl-Istudju 1 ta' Artrite Psorjatika (SPIRIT-P1), pazjenti b'artrite psorjatika u li qatt qabel ma kienu rċevew terapija bijoloġika ġew mogħtija b'mod arbitrarju injezzjonijiet minn taħt il-ġilda ta' plaċebo, adalimumab 40 mg darba kull ġimagħtejn (fergħa ta' referenza għall-kontroll attiv), Taltz 80 mg darba kull ġimagħtejn (Q2W), jew 80 mg darba kull 4 ġimgħat (Q4W).
English: Maintenance of Response and Efficacy at Week 60 (Studies UNCOVER-1 and UNCOVER-2)
Maltese: UNCOVER-1 u UNCOVER-2)
English: You will hear a second loud click in about 5 to 10 seconds after the first one.
Maltese: Inti se tisma' t-tieni klikk qawwija f'madwar 5 sa 10 sekondi mill-ewwel waħda.
English: Taltz can be left out of the fridge for up to 5 days at a temperature not above 30 ºC.
Maltese: Taltz jista' jitħalla barra mill-friġġ sa 5 ijiem f'tempertura li ma taqbiżx it-30 ºC.
English: In SPIRIT-P1and SPIRIT-P2, improvements were shown in all components of the ACR scores including patient assessment of pain.
Maltese: F'SPIRIT-P1u SPIRIT-P2, titjib intwera f'kull komponent tal-punteġġi ACR, inkluż l-evalwazzjoni talpazjent fuq l-uġigħ.
English: Efficacy in Non-Responders to Etanercept: For patients identified as an sPGA (0,1) non-responder to etanercept at Week 12 in UNCOVER-2 (N = 200) and who were switched to Taltz 80 mg Q4W after a 4 week washout period, 73 % and 83.5 % of patients were able to achieve sPGA (0,1) and PASI 75, respectively, after 12 weeks of being treated with Taltz.
Maltese: ma wiġbux għal etanercept f'Ġimgħa 12 f'UNCOVER-2 (N = 200) u li nqalbu fuq Taltz 80 mg Q4W wara perjodu ta' 4 ġimgħat mingħajr mediċina għall-kundizzjoni, 73% u 83.5% tal-pazjenti kienu kapaċi jiksbu sPGA (0,1) u PASI 75, rispettivament, wara 12-il ġimgħa li kienu qed jiġu ttrattati b'Taltz.
English: Based on population pharmacokinetic analysis with a limited number of elderly patients (n = 94 for age ≥ 65 years and n = 12 for age ≥ 75 years), clearance in elderly patients and patients less than 65 years of age was similar.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni b'numru limitat ta' pazjenti anzjani (n = 94 għall età ≥ 65 sena u n = 12 għall-età ta' ≥ 75 sena), it-tneħħija f'pazjenti anzjani u pazjenti li għandhom inqas minn 65 sena kienet tixxiebah.
English: In the placebo-controlled period of the phase III clinical studies in plaque psoriasis, infections were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of patients treated with placebo.
Maltese: III ta' psorjasi bil-plakka, ġew irrappurtati infezzjonijiet f'27.2% tal-pazjenti ttrattati b'Taltz sa 12-il ġimgħa meta mqabbla ma' 22.9% tal pazjenti ttratti bi plaċebo.
English: Taltz is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
Maltese: Taltz mhuwiex irrakkomandat għal tfal u adolexxenti ta' taħt it-18-il sena minħabba li ma ġiex studjat f'dan il-grupp ta' età.
English: The frequency of neutropenia and thrombocytopenia in psoriatic arthritis clinical studies is similar to that observed in the plaque psoriasis studies.
Maltese: Il-frekwenza tan-newtropenija u tat-tromboċitopenija fl-istudji kliniċi tal-artrite psorjatika kienu simili għal dawk osservati fl-istudji tal-psorjasi bil-plakka.