FrancophonIA/ELRC3.0 huggingface dataset:
English: HEPES N-(2-hydroxyethyl) piperazine-N´-(2-ethanesulfonic acid) Sodium hydroxide
Maltese: Aċidu Lattobijoniku HEPES N-(2-idrossietil) piperażina-N´-(2-aċidu etanesulfoniku)
English: MARKETING AUTHORISATION HOLDER EquiCord-YMAS S.L.
Maltese: EquiCord-YMAS S.L.
English: Excipients: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' ingredjenti mhux attivi, ara s-Sezzjoni 6.1.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni benefiċċju/riskju mill-veterinarju responsabbli.
English: For intraarticular use.
Maltese: Użu intraartikulari.
English: The veterinary medicinal product was demonstrated to be efficacious in horses affected by osteoarthritis in the metacarpo-phalangeal joint, distal interphalangeal joint, and tarsometatarsal/ distal intertarsal joint.
Maltese: Il-prodott mediċinali veterinarju ntwera li huwa effikaċi fiż-żwiemel affettwati mill-osteoartrite fil-ġog metakarpo-falanġeali, il-ġog interfalanġeali distali, u l-ġog tarsometatarsali/ distali intertarsali.
English: A second administration of the product at the recommended dose to healthy young horses in the same joint, 28 days after the first administration at the recommended dose, led to an increase in frequency and severity of inflammation related to the treated joint (8/8 horses) and to an increase in the severity of the lameness observed (3/8 horses; up to grade 4/5 according to the American Association of Equine Practitioners lameness scale (AAEP)) compared to the first treatment.
Maltese: It-tieni amministrazzjoni tal-prodott bid-doża rakkomandata lil żwiemel żgħar b'saħħithom fl-istess ġog, 28 jum wara l-ewwel amministrazzjoni bid-doża rakkomandata, wasslet għal żieda fil-frekwenza u fil-gravità tal-infjammazzjoni relatata mal-ġog ikkurat (8 minn kull 8 żwiemel) u għal żieda fil gravità taz-zappip osservat (3 minn kull 8 żwiemel, sa grad 4 minn 5 skont l-iskala taz-zappip talAssoċjazzjoni Amerikana tal-Prattikanti tal-Ekwini (AAEP)) meta mqabbla mal-ewwel kura.
English: PACKAGE SIZE One 1 ml vial.
Maltese: Kunjett wieħed ta' 1 ml.
English: The potential of EUC-MSCs to secrete PGE2 with and without stimulation by synovial fluid has been demonstrated in studies in vitro.
Maltese: Il-potenzjal tal-EUC-MSCs li jissekretaw il-PGE2 bi stimulazzjoni u mingħajrha permezz ta' fluwidu sinovjali ntwera fl-istudji in vitro.
English: BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT Lott:
English: Do not administer simultaneously with any other intraarticular veterinary medicinal product.
Maltese: Tapplikax b'mod simultanju ma' prodotti mediċinali veterinarji intraartikulari oħra.
English: ROUTE(S) OF ADMINISTRATION Intraarticular use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: The product should only be administered by a veterinary surgeon.
Maltese: Il-prodott għandu jiġi amministrat minn kirurgu veterinarju.
English: Intraarticular administration of a 2x dose (30x106/2ml) of HorStem to 4 years old and older healthy horses led to lameness in 5/6 animals and to signs of inflammation in all animals.
Maltese: Amministrazzjoni intraartikulari ta' doża 2x (30x106/2ml) ta' HorStem lil żwiemel b'saħħithom li għandhom erba' snin u aktar wasslet għal zappip f'5 minn kull sitt 6 annimali u għal sinjali ta' infjammazzjoni fl-annimali kollha.
English: A single intraarticular injection of 1 ml (15x106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Maltese: Injezzjoni intraartikulari waħda ta' 1 ml (15x106 ċelloli staminali mesenkimali tal-kurdun umbiliku ekwin) fil-ġog affettwat.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurati) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1 000 annimal ikkurati) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10 000 annimal ikkurati) - rari ħafna (anqas minn annimal wieħed f'10,000 annimal ikkurati, inklużi rapporti iżolati).
English: Suspension for injection.
Maltese: Sospensjoni għall-injezzjoni.
English: These pharmacodynamic properties may be also relevant for equine umbilical cord derived MSCs (EUC-MSCs) but have not been demonstrated in proprietary studies conducted with the product.
Maltese: Dawn il-kwalitajiet farmakodinamiċi jistgħu jkunu rilevanti wkoll għall-MSCs derivati mill-kurdun umbilikali tal-ekwini (EUC-MSCs) iżda għadhom ma ntwerewx fi studji tal-karatteristiċi mwettqa fuq il-prodott.
English: Calcium chloride
Maltese: Klorur tal-kalċju
English: To be administered only by a veterinary surgeon
Maltese: Għandu jiġi amministrat biss minn kirurgu veterinarju
English: Dosage A single intraarticular injection of 1 ml (15x106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Maltese: Dożaġġ Injezzjoni intraartikulari waħda ta' 1 ml (15x106 ċelloli staminali mesenkimali tal-kurdun umbiliku ekwin) fil-ġog affettwat.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Route of administration:
Maltese: 4.9 Ammonti li jingħataw u l-metodu ta' amministrazzjoni Metodu ta' amministrazzjoni:
English: The active substance, mesenchymal stem cells, is considered as not falling within the scope of the MRL regulation, as it is covered by the entry for stem cells in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva, ċelloli staminali mesenkimali, titqies bħala li ma taqax fil-kamp ta' applikazzjoni tar regolament dwar l-MRL, minħabba li hija koperta mill-entrata għaċ-ċelloli staminali fil-lista ta' sustanzi meqjusa bħala li ma jaqgħux fil-kamp ta' applikazzjoni tar-Regolament (KE) Nru 470/2009.
English: Equine umbilical cord mesenchymal stem cells (EUC-MSCs)
Maltese: Ċelloli staminali mesenkimali tal-kurdun umbiliku ekwin (EUC-MSCs) 15x106
English: Potassium chloride
Maltese: Klorur tal-manjeżju
English: In case of severe inflammation, administration of symptomatic treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) could be necessary.
Maltese: F'każ ta' infjammazzjoni severa, lamministrazzjoni ta' kura sintomatika b'Mediċini Antinfjammatorji Nonsterojdali (NSAIDs) tista' tkun neċessarja.
English: ADVICE ON CORRECT ADMINISTRATION Do not apply simultaneously with other intraarticular veterinary medicinal products.
Maltese: Tamministrax b'mod simultanju ma' kwalunkwe prodott mediċinali veterinarju intraartikulari ieħor.
English: 15x106 /ml Equine umbilical cord mesenchymal stem cells
Maltese: 15x106 /ml Ċelloli staminali mesenkimali tal-kurdun umbiliku ekwin 3. KONTENUT BĦALA
English: In order to further support the link between PGE2 production and a clinically-relevant therapeutic effect, the marketing authorisation holder shall conduct and submit an updated and validated potency assay (a product specific in vitro model) to the CVMP/EMA for evaluation before batch release and placing the product on the market.
Maltese: id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jwettaq u jissottometti assaġġ ta' potenza aġġornat u validat (mudell in vitro speċifiku għall-prodott) lis-CVMP/lill-EMA għall-evalwazzjoni qabel il-ħruġ tal-lott u t-tqegħid fis-suq tal-prodott.
English: Cloudy colourless suspension.
Maltese: Sospensjoni mċajpra mingħajr kulur.
English: ADVERSE REACTIONS
Maltese: KONTRAINDIKAZZJONIJIET
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar il-kompatibbiltà, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Potassium hydroxide
Maltese: Idrossidu tal-potassju
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/226/001 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2019
Maltese: Data tal-ewwel awtorizzazzjoni: 19/06/2019
English: Mesenchymal stem cells have immunomodulatory and anti-inflammatory properties that may be attributed to their paracrine activity, -e.g. prostaglandin (PGE2) secretion, and can possess tissue regenerative properties.
Maltese: Iċ-ċelloli staminali mesenkimali għandhom kwalitajiet immunomodulatorji u antiinfjammatorji li jistgħu jiġu attribwiti għall-attività parakrina tagħhom, -eż. sekrezzjoni tal-prostagladina (PGE2), u jistgħu jkollhom kwalitajiet riġenerattivi tat-tessuti.
English: Acute synovitis with an acute onset of severe lameness, joint effusion and pain on palpation was reported 24 hours after administration of the veterinary medicinal product.
Maltese: 24 siegħa wara l-amministrazzjoni tal-prodott mediċinali veterinarju ġew irrappurtati sinovite akuta b'bidu akut ta' zappip sever, effużjoni tal-ġogi u wġigħ mal-palpazzjoni.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT HorStem suspension for injection for horses
Maltese: VETERINARJU HorStem sospensjoni għall-injezzjoni għaż-żwiemel
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZI BIJOLOĠIĊI ATTIVI U MANIFATTUR RESPONSABBLI
English: Active Substance: 15x106 Equine umbilical cord mesenchymal stem cells
Maltese: Kull kunjett fih: Sustanza Attiva: 15x106 Ċelloli staminali mesenkimali tal-kurdun umbiliku ekwin
English: In 5/6 horses, the adverse reactions were mild and resolved spontaneously within 28 days.
Maltese: F'5 minn kull 6 żwiemel, l-effetti mhux mixtieqa kienu ħfief u ġew riżolti b'mod spontanju fi żmien 28 jum.
English: • Risk management plan:
Maltese: • Pjan tal-ġestjoni tar-riskju:
English: Intraarticular use.
Maltese: Mhux applikabbli.
English: Interaction with other medicinal products and other forms of interactions
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni:
English: C. STATEMENT OF THE MRLs
Maltese: 4. DAQS TAL-PAKKETT
English: An increase in mild lameness was observed 24 hours after HorStem administration.
Maltese: 24 siegħa wara l-amministrazzjoni ta' HorStem ġiet osservata żieda ħafifa fiz-zappip.
English: Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an associated risk of thrombosis.
Maltese: It-tqegħid korrett tal-labra huwa kruċjali biex tiġi evitata injezzjoni aċċidentali f'vażi u riskju assoċjat ta' trombożi.
English: Sodium hydroxide
Maltese: Dekstrożju Sukrożju
English: Potassium phosphate
Maltese: Mhux assenjat
English: To what extent EUC-MSCs from this product persist after intraarticular administration to horses is not known as no proprietary biodistribution studies have been conducted with HorStem.
Maltese: Kemm l-EUC-MSCs minn dan il-prodott jippersistu wara l-amministrazzjoni intraartikulari liż-żwiemel mhuwiex magħruf minħabba li għadu ma twettaq l-ebda studju tal-bijodistribuzzjoni tal-karatteristiċi fir rigward ta' HorStem.
English: One horse required symptomatic treatment (NSAID) and its lameness resolved by day 14.
Maltese: Żiemel wieħed kien jeħtieġ kura sintomatika (NSAID) u z-zappip tiegħu ġie riżolt sa jum 14.
English: The starting date of the reporting scheme (Day 0) shall be the date of first release of a batch that has been tested with the updated and validated potency assay.
Maltese: Id-data ta' bidu tal-iskema ta' rapportar (Jum 0) għandha tkun id-data tal-ewwel rilaxx ta' lott li jkun ġie ttestjat bl-assaġġ tal-potenza aġġornat u validat.
English: L- Glutathione
Maltese: U L-UŻU
English: TARGET SPECIES Horses
Maltese: Kodiċi ATC veterinarju:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effett(i) mhux mixtieqa)
English: (minimal)
Maltese: (minimu)
English: Via Gramsci 731/733 50019 Sesto Fiorentino (FI) Italy.
Maltese: Via Gramsci 731/733 50019 Sesto Fiorentino (FI) L-Italja.
English: Influenzai, Rhinitis, Oral candidiasisd, Conjunctivitisi, Cellulitise
Maltese: Influwenzai, Rinite, Kandidjasi oralid, Konġuntivitei, Ċellulitee
English: 2 INJECT 2a
Maltese: 2 INJETTA 2a
English: Tinea infection, Herpes simplex (mucocutaneous)c
Maltese: Infezzjoni b'tinea, Herpes Simplex (mukokutanju)c
English: Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.
Maltese: Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), L-Italja.
English: Week 52 Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab**
Maltese: Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab**
English: Change in modified Total Sharp Score in SPIRIT-P1
Maltese: Il-bidla fil-modified Total Sharp Score fi SPIRIT-P1
English: Date of first authorisation: 25 April 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 25 ta' April 2016
English: Ixekizumab does not bind to ligands IL-17B, IL-17C, IL-17D, IL-17E or IL-17F.
Maltese: Ixekizumab ma jintrabatx mal-ligands IL-17B, IL-17C, IL-17D, IL-17E jew IL-17F.
English: 159 (41.6)a sPGA of “0” (clear)
Maltese: 159 (41.6)a sPGA ta “0”
English: Eli Lilly Kinsale Limited Dunderrow
Maltese: Eli Lilly Kinsale Limited.
English: UNCOVER-3 enrolled 1,346 patients.
Maltese: UNCOVER-3 irreġistra fih 1,346 pazjent.
English: Subcutaneous use.
Maltese: Użu subkutaneju.
English: There is limited information in subjects aged ≥ 75 years.
Maltese: Hemm informazzjoni limitata f'individwi li għandhom ≥ 75 sena.
English: 354 (81.8)a sPGA of “0” (clear)
Maltese: 354 (81.8)a sPGA ta' “0”
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: UNCOVER-1 enrolled 1,296 patients.
Maltese: UNCOVER-1 irreġistra fih 1,296 pazjent.
English: Mean (SD) Cmax,ss, and C trough,ss estimates are 21.5 (9.16) µg/ml, and 5.23 (3.19) µg/ml.
Maltese: L-istimi tal-medji (SD) ta' Cmax,ss, u C trough,ss huma 21.5 (9.16) µg/ml, u 5.23 (3.19) µg/ml.
English: Taltz must not be given to patients with active tuberculosis (TB).
Maltese: Taltz ma jistax jingħata lill-pazjenti b'tuberkulożi (TB - tuberculosis) attiva.
English: Taltz contains sodium
Maltese: Taltz fih sodium
English: Minimal Disease Activity (MDA) n (%) Week 24
Maltese: Attività Minima ta' Mard (MDA- Minimal Disease Activity ) n (%)
English: BATCH NUMBER
Maltese: Fuq numru ta'
English: sPGA of Genitalia “0” or “1” sPGA “0” or “1” DLQI 0,1b
Maltese: sPGA tal-Ġenitali “0” or “1” sPGA “0” or “1”
English: UNCOVER-2 enrolled 1,224 patients.
Maltese: UNCOVER-2 irreġistra fih 1,224 pazjent.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC13
Maltese: Immunosoppressanti, inibituri ta' interleukin, Kodiċi ATC:
English: Other medicines and Taltz
Maltese: Mediċini oħra u Taltz
English: Cytochrome P450 Substrates
Maltese: Sustrati taċ-Ċitokrom P450
English: Immune system disorders
Maltese: Disturbi fis-sistema immunig
English: For both Taltz Q2W and Q4W: b p<0.01 and c p<0.001 compared with placebo.
Maltese: Kemm għal Taltz Q2W u Q4W: b p<0.01 u c p<0.001 meta mqabbla ma' plaċebo.
English: ADRs from clinical studies and postmarketing reports (Table 1) are listed by MedDRA system organ class.
Maltese: ADRs minn studji kliniċi u rapporti wara t-tqegħid fis-suq (Tabella 1) huma elenkati skont il-klassi tas-sistemi u tal-organi MedDRA.
English: Number of patients (%)
Maltese: Numru ta' pazjenti (%)
English: Taltz was associated with a fast onset of efficacy with > 50 % reduction in mean PASI by Week 2 (Figure 1).
Maltese: Taltz kien assoċjat ma' bidu malajr ta' effikaċja bi tnaqqis ta' > 50% fil-medja ta' PASI sa Ġimgħa 2 (Figura 1).
English: Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (< 3 pM) and specificity to interleukin 17A (both IL-17A and IL-17A/F).
Maltese: Ixekizumab huwa antikorp monoklonali IgG4 li jintrabat b'affinità kbira (< 3 pM) u b'mod speċifiku ma' interleukin 17A (kemm IL-17A u IL-17A/F).
English: ACR20 Responders, %
Maltese: Responders, %
English: 3% of patients exposed to Taltz had a shift from a normal baseline platelet value to <150,000 platelet cells/mm3 to ≥75,000 cells/mm3.
Maltese: 3% tal-pazjenti esposti għal Taltz kellhom bidla minn valur ta' plejtlits fil-linja bażi normali għal <150,000 ċelluli ta' plejtlits/mm3 sa ≥75,000 celluli/mm3.
English: ONLY.
Maltese: Co.
English: Urticaria, Rash, Eczema,
Maltese: Urtikarja,Raxx, Ekżema
English: ACR 50 and PASI 100 in patients with ≥3% BSA psoriasis skin involvement at baseline, n (%)
Maltese: ACR 50 u PASI 100 f'pazjenti li fil-linja bażi kellhom ≥3% BSA tal-ġilda affettwata mill-psorjasi, n (%)d
English: (nasopharyngitis).
Maltese: (injezzjoni subkutaneja).
English: 292 (83.2)a sPGA of “0” (clear)
Maltese: 292 (83.2)a sPGA ta'
English: TALTZ Placebo Difference from placebo (95% CI)
Maltese: TALTZ Plaċebo Id-differenza minn plaċebo (95% CI)
English: Serious infections were reported in 1.6 % of patients treated with Taltz (1.5 per 100 patient years).
Maltese: Infezzjonijiet serji ġew irrapportati f'1.6% millpazjenti ttrattati b'Taltz (1.5 minn kull 100 pazjent kull sena).
English: The bioavailability of Taltz in psoriatic arthritis patients was in the range of 61-84% on the basis of the population pharmacokinetic model.
Maltese: Il-bijodiponibbiltà ta' Taltz f'pazjenti b'artrite psorjatika kienet fil-marġni ta' 61-84 % abbażi tal-mudell farmakokinetiku tal-popolazzjoni.
English: Abbreviations: ADA = adalimumab; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; Q2W = Taltz 80 mg every 2 weeks; LSM = least squares mean; N = number of patients in the analysis population; PBO = placebo; SE = standard error; SD = standard deviation.
Maltese: ADA = adalimumab; CI = interval ta' kunfidenza (confidence interval); Q4W = Taltz 80 mg kull 4 ġimgħat; Q2W = Taltz 80 mg kull ġimagħtejn; LSM = least squares mean; N = numru ta' pazjenti fil-popolazzjoni taħt analiżi; PBO = plaċebo; SE = standard error;
English: The rate of serious infections was 0.4 % for etanercept and 0.5 % for Taltz.
Maltese: Ir-rata ta' infezzjonijiet serji kienet 0.4% għal etanercept u 0.5% għal Taltz.
English: Difference from Placebo (95% CI)
Maltese: Differenza minn Plaċebo (95% CI)
English: - bacterial skin infection.
Maltese: - infezzjoni batterjali tal-ġilda.
English: The efficacy and safety of Taltz were also evaluated versus etanercept (UNCOVER-2 and UNCOVER-3).
Maltese: L-effikaċja u ssigurtà ta' Taltz ġew ivvalutati wkoll kontra etanercept (UNCOVER-2 u UNCOVER-3).
English: Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Maltese: Taltz huwa indikat għat-trattament ta' psorjasi bil-plakka minn moderata sa severa fl-adulti li huma kandidati għal terapija sistemika.
English: N with baseline GPSS Itch NRS Score ≥3 N=62 N=60 GPSS Genital Itch (≥3 point improvement) N with baseline SFQ Item 2 Score ≥2
Maltese: N b'punteġġ fil-GPSS Itch NRS ta' ≥3 fil-linja bażi
English: Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Maltese: Eċċipjenti: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; ilma għall injezzjonijiet.
English: The effect of ixekizumab on human fertility has not been evaluated.
Maltese: Ma ġiex stmat l-effett ta' ixekizumab fuq il-fertilità umana.
English: A total of 3,119 patients were evaluated (1,161 patients on 80 mg every 4 weeks (Q4W), 1,167 patients on 80 mg every 2 weeks (Q2W) and 791 patients on placebo).
Maltese: Ġew ivvalutati total ta' 3,119-il pazjent (1,161 pazjent fuq 80 mg kull 4 ġimgħat (Q4W), 1,167 pazjent fuq 80 mg kull ġimagħtejn (Q2W) u 791 pazjent fuq plaċebo).
English: b Upper respiratory tract infection includes nasopharyngitis and upper respiratory tract infection c Herpes simplex (mucocutaneous) is defined as events with the preferred terms Oral herpes, Herpes simplex, Genital herpes, Herpes dermatitis, and Genital herpes simplex d Oral candidiasis defined as events with the preferred terms oral candidiasis and oral fungal infection e Cellulitis includes staphylococcal and external ear cellulitis, and erysipelas f In the plaque psoriasis studies, injection site reactions were more common in subjects with a body weight < 60 kg compared with the group with a body weight ≥ 60 kg (25 % vs. 14 % for the combined Q2W and Q4W groups).
Maltese: Infezzjoni fin-naħa ta' fuq tal-apprat tan-nifs tinkludi nażofarinġite u infezzjoni fin-naħa ta' fuq tal apparat tan-nifs cHerpes simplex (mukokutanju) huwa mfisser bħala avvenimenti bit-termini preferuti Herpes orali, Herpes simplex, Herpes ġenitali, Herpes fid-dermatite u Herpes simplex ġenitalidKandidjasi orali ddefinita bħala avvenimenti bit-termini ppreferuti kandidjasi orali u infezzjoni orali bil-fungu eĊellulite tinkludi ċellulite bi stafilokokkus u tan-naħa ta' barra tal-widna, u irsipli fFl-istudji tal-psorjasi bil-plakka, ir-reazzjonijiet fis-sit tal-injezzjoni kienu aktar komuni f'individwi b'piż tal-ġisem ta' < 60 kg meta mqabbla mal-grupp b'piż tal-ġisem ta' ≥ 60 kg (25% vs. 14% għall gruppi ta' Q2W u Q4W f'daqqa).
English: In addition, the corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000
Maltese: hija 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); rari ħafna (< 1/10,000).
English: At Week 12 and across studies, Taltz was associated with statistically significant improvement in Health-related Quality of Life as assessed by mean decrease ranges from baseline in the Dermatology Life Quality Index (DLQI) (Taltz 80 mg Q2W from -10.2 to -11.1, Taltz 80 mg Q4W from -9.4 to10.7, etanercept from -7.7 to -8.0 and placebo -1.0 to -2.0).
Maltese: Kwalità tal-Ħajja tad-Dermatoloġija (DLQI - Dermatology Life Quality Index) (Taltz 80 mg Q2W minn -10.2 sa -11.1, Taltz 80 mg Q4W minn -9.4 sa -10.7, etanercept minn -7.7 sa -8.0 u plaċebo -1.0 sa -2.0).
English: Maintenance of Response at Week 60
Maltese: Manteniment tar-rispons f'Ġimgħa 60
English: A total of 678 patients were evaluated (229 patients on 80 mg every 4 weeks (Q4W), 225 patients on 80 mg every 2 weeks (Q2W) and 224 patients on placebo).
Maltese: Ġew ivvalutati total ta' 678 pazjent (229 pazjent fuq 80 mg kull 4 ġimgħat (Q4W), 225 pazjent fuq 80 mg kull ġimagħtejn (Q2W) u 224 pazjent fuq plaċebo).
English: There will be a loud click.
Maltese: Se jkun hemm klikk qawwija.
English: sPGA of “0” (clear) or
Maltese: sPGA ta' “0”
English: b p<0.01; c p<0.001 compared with placebo.
Maltese: b p<0.01; c p<0.001 meta mqabbla ma' plaċebo.
English: Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [4.3%; 12.1%] ; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and superiority on PASI 100 at Week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were the major secondary endpoints in the study.
Maltese: ADA; 95% intervall ta' kunfidenza [-4.3%; 12.1%]; analiżi PPS ta' Taltz: 52.3%, ADA: 53.1%, differenza: -0.8% [CI: -10.3%; 8.7%]) u kien superjuri fuq PASI 100 fl-24 Ġimgħa (60.1 % b'Taltz vs 46.6% b'ADA,