FrancophonIA/ELRC3.0 huggingface dataset:
English: Finland Sandoz A/S Edvard Thomsens Vej 14 Copenhagen S 2300 Denmark
Maltese: Il-Finlandja Sandoz A/S Edvard Thomsens Vej 14 Copenhagen S 2300
English: Orlistat STADA 60 mg 60 mg
Maltese: Orlistat STADA 60 mg
English: 19, Pelplinska street 83-200 Starogard Gdanski Poland
Maltese: 19, Pelplińska Street 83-200 Starogard Gdański Poland
English: Orlistat-ratiopharm 120 mg Hartkapseln
Maltese: Orlistatratiopharm 120 mg Hartkapseln
English: ORLISTAT SANDOZ 120 mg, gélule
Maltese: SANDOZ 120 mg, gélule
English: Lithuania Pharmaceutical Works POLPHARMA S.A., 19
Maltese: Il-Litwanja Pharmaceutical Works POLPHARMA S.A.,
English: ul.
Maltese: MG
English: Denmark Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Maltese: DK-2800 Kongens Lyngby, Denmark
English: Latvia Teva Pharma B.V., Computerweg 10, 3542DR Utrecht, The Netherlands
Maltese: Teva Pharma B.V., Computerweg 10, 3542DR Utrecht,
English: Norway Sandoz A/S, Edvard Thomsens Vej 14, 2300 København S,
Maltese: In-Norveġja Sandoz A/S, Edvard Thomsens Vej 14, 2300
English: Orlistat Teva
Maltese: ORLISTAT
English: Latvia Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
Maltese: Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
English: ORLISTAT TEVA 120 mg, gélule
Maltese: TEVA 120 mg, gélule
English: ORLISTAT SANDOZ 60 mg, gélule
Maltese: SANDOZ 60 mg, gélule
English: ORLISTAT TEVA 60 mg, gélule
Maltese: TEVA 60 mg, gélule
English: Orlistat Sandoz 60 mg 60 mg
Maltese: Orlistat Sandoz 60 mg
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Maltese: Ir-Renju Unit Teva UK Limited, Brampton Road,
English: Address: 19, Pelplińska Street, 83-200 Starogard Gdański, Poland
Maltese: 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
English: Orlistat-ratiopharm 60 mg Hartkapseln
Maltese: Orlistatratiopharm 60 mg Hartkapseln
English: Belgium Pharmaceuticals Works Pharma SA
Maltese: Pharmaceutical Works POLPHARMA SA
English: Orlistat "Teva"
Maltese: ANNESS I LISTA TA`
English: Orlistat EG
Maltese: L-Isvezja
English: Lithuania Pharmaceutical Works POLPHARMA S.A., 19 Pelplinska Street, Starogard Gdanski 83-200 Poland
Maltese: Pharmaceutical Works Polpharma S.A. 19, Pelplinska street 83-200 Starogard Gdanski Poland
English: Poland Pharmaceutical Works POLPHARMA SA 19, Pelplińska Street 83-200 Starogard Gdański Poland
Maltese: Pharmaceuticals Works Pharma SA 19, Pelplinska street 83-200 Starogard Gdanski Poland
English: 19, Peplinska Street Starogar Gdanski
Maltese: Il-Bulgarija Pharmaceutical Works Polpharma S.A 19, Peplinska Street Starogar Gdanski
English: The
Maltese: MEMBRI
English: EMA/482876/2014 EMEA/H/C/001092
Maltese: EMEA/H/C/001092
English: The full EPAR for Urorec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Urorec, silodosin, is an alpha adrenoreceptor antagonist.
Maltese: Is-sustanza attiva f'Urorec, is-silodosin, hija antagonista alfaadrenoċettur.
English: Other information about Urorec
Maltese: Informazzjoni oħra dwar Urorec
English: The European Commission granted a marketing authorisation valid throughout the European Union for Urorec on 29 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Urorec valida fl-Unjoni Ewropea kollha fid-29 ta' Jannar 2010.
English: Urorec is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Maltese: Urorec jintuża għall-kura tas-sintomi ta' iperplasija beninna tal-prostata (Benign Prostatic HyperplasiaBPH, glandola tal-prostata mkabbra) fl-adulti.
English: This is a summary of the European public assessment report (EPAR) for Urorec.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Urorec.
English: Why has Urorec been approved?
Maltese: Għaliex ġie approvat Urorec?
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Maltese: Is-sindromu tal-iris mitluqa waqt operazzjoni (Intra-operative Floppy Iris Syndrome - IFIS) iseħħ f'xi pazjenti li jkunu qegħdin jieħdu antagonisti alfaadrenoċetturi u jista' jwassal għal komplikazzjonijiet waqt operazzjoni tal-katarretti.
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Urorec after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Maltese: Fit-tielet studju, l-IPSS kien madwar 19-il punt qabel il-kura, u naqas b'7.0 punti fl-irġiel li ħadu Urorec wara 12-il ġimgħa, 6.7 punti fl-irġiel li ħadu tamsulosin u 4.7 punti fl-irġiel li ħadu plaċebo.
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Urorec, and by around 3.5 points in the men who took placebo.
Maltese: Wara 12-il ġimgħa, kien naqas b'madwar 6.4 punti fl-irġiel li ħadu Urorec, u b'madwar 3.5 punti fl-irġiel li ħadu plaċebo.
English: Urorec is a medicine that contains the active substance silodosin.
Maltese: Urorec huwa mediċina li fiha s-sustanza attiva silodosin.
English: What is Urorec?
Maltese: Kif jaħdem Urorec?
English: Urorec has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH.
Maltese: Urorec tqabbel ma' plaċebo (kura finta) fi tliet studji ewlenin li kienu jinvolvu aktar minn 1,800 raġel b'BPH.
English: What is the risk associated with Urorec?
Maltese: X'inhu r-riskju assoċjat ma' Urorec?
English: It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Maltese: Taħdem billi timblokka riċetturi msejħin alfaadrenoċetturi 1A fil-glandola tal-prostata, fil-bużżieqa tal-awrina u fl-uretra (ilpajp li jwassal mill-bużżieqa tal-awrina sa barra l-ġisem).
English: The most common side effect with Urorec (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Maltese: L-effett sekondarju l-aktar komuni li deher b'Urorec (li deher f'iktar minn pazjent 1 minn kull 10) huwa tnaqqis fl-ammont ta' semen li joħroġ waqt l-eġakulazzjoni.
English: A risk management plan has been developed to ensure that Urorec is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jiġi żgurat li Urorec jintuża bl-aktar mod sigur possibbli.
English: How does Urorec work?
Maltese: X'inhu Urorec?
English: In addition, the company that makes Urorec will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Maltese: Barra minn hekk, il-kumpanija li tagħmel Urorec se tiżgura li l-kirurgi tal-għajnejn jiġu pprovduti b'informazzjoni dwar l-IFIS fl-Istati Membri kollha fejn il-mediċina sejra titqiegħed fis-suq.
English: In the two studies where Urorec was compared only with placebo, the IPSS was around 21 points at the start of the study.
Maltese: Fiżżewġ studji fejn Urorec tqabbel ma' plaċebo biss, l-IPSS kien madwar 21 punt fil-bidu tal-istudju.
English: The effects of Urorec were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Urorec għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: One of these studies also compared Urorec with tamsulosin (another medicine used for BPH).
Maltese: Wieħed minn dawn l-istudji qabbel ukoll Urorec ma' tamsulosin (mediċina oħra li tintuża għal BPH).
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Maltese: Urorec kien aktar effikaċi minn plaċebo u effikaċi daqs tamsulosin fit-tnaqqis tas-sintomi ta' BPH.
English: Infiltration
Maltese: Infiltrazzjoni
English: John Tsaprazis SA 157 Michalakopoulou Str.
Maltese: John Tsaprazis SA 157 Michalakopoulou Str. 11527, Athens Greece
English: Germany Septodont GmbH Felix-Wankel-Str. 9
Maltese: Il-Ġermanja Septodont GmbH Felix-Wankel-Str. 9
English: Infiltration Periodontal use
Maltese: Infiltrazzjoni Użu perjodontali
English: Septanest Z Adrenaliną
Maltese: Septanest Cu Adrenalină
English: Adrenalina, tartarato 0.0182mg/ml
Maltese: Adrenaline tartrate 0.0182mg/ml
English: Belgium Septodont Nv-Sa 87 Avenue de la Constitution
Maltese: Il-Belġju Septodont Nv-Sa 87 Avenue de la
English: Adrenalina, tartarato 0.0091 mg/ml
Maltese: Adrenaline tartrate 0.0091 mg/ml
English: 40 mg/0,01 mg v 1 ml raztopina za injiciranje
Maltese: Septanestepi 40 mg/0,01 mg v 1 ml raztopina za injiciranje
English: Septodont GmbH Felix-Wankel-Str. 9 D - 53859
Maltese: L-Awstrija Septodont GmbH Felix-Wankel-Str. 9
English: Portugal
Maltese: Germany
English: Dental use Infiltration and perineural use in the oral cavity
Maltese: Użu dentali Użu għallinfiltrazzjoni u għal madwar innervituri filkavità orali
English: 94107 Saint-Maur-desFossés Cedex France
Maltese: Septodont SAS 58, rue du Pont de Créteil 94107 Saint-Maur-DesFossés Cedex France
English: Dental use Submucosal use
Maltese: Adrenalinée au solution injectable à usage dentaire
English: Articaína, cloridrato 40 mg/ml
Maltese: Septocaine Forte 40 mg/ml mg/ml
English: Adrenaline 0.005 mg/ml adrénaline (tartrate d'): non précisé
Maltese: Adrenaline 0.005 mg/ml adrenaline tartrate: mhux speċifikat
English: Adrenaline 0.005mg/ml adrénaline (tartrate d') : non précisé
Maltese: Adrenaline 0.005mg/ml adrenaline tartrate: mhux speċifikat
English: Adrenaline 0.01 mg/ml adrénaline (tartrate d') : non précisé
Maltese: Adrenaline 0.01 mg/ml adrenaline tartrate: mhux speċifikat
English: Lithuania Septodont 58 rue du Pont de Créteil
Maltese: Il-Litwanja Septodont 58 rue du Pont de Créteil 94100
English: Sweden Specialites Septodont 58, rue du Pont de Créteil
Maltese: Il-Finlandja Specialites Septodont. 58, rue du Pont de Créteil 94100
English: Septodont SAS 58, rue du Pont de Créteil
Maltese: Is-Slovenja Septodont 58, rue du Pont de Créteil 94100
English: Via bucal
Maltese: Ċipru
English: Laboratories Septodont 58, rue du Pont de Créteil
Maltese: Specialites Septodont 58, rue du Pont de Créteil 94100
English: Niederkassel-Mondorf Germany
Maltese: D - 53859 NiederkasselMondorf
English: 40 mg/ml + 5 microg/ml
Maltese: Septanest Forte 40 mg/ml mg/ml
English: (E171), macrogol 3350, and triacetin (E1518).
Maltese: (E171), macrogol 3350, u triacetin (E1518).
English: Study III (ORAL Standard)
Maltese: III (ORAL Standard)
English: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Maltese: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
English: Study I (ORAL Solo)
Maltese: Studji I (ORAL Solo)
English: Study VII (ORAL Strategy)
Maltese: Studju VII (ORAL Strategy)
English: P Ratio and 90% CI
Maltese: PK Proporzjon u 90% CI
English: CYP Rifampicin
Maltese: Induttur ta' CYP Rifampicin
English: Study II (ORAL Sync)
Maltese: II (ORAL Sync)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 22 Marzu 2017
English: • fluconazole, ketoconazole, clotrimazole, itraconazole, and voriconazole, used to treat fungal infections
Maltese: • fluconazole, ketoconazole, clotrimazole, itraconazole, u voriconazole, użati sabiex jikkuraw infezzjonijiet fungali
English: OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Maltese: OCTAVE Induzzjoni 1 OCTAVE Induzzjoni 2 OCTAVE Sostenn
English: Ratio relative to reference
Maltese: Proporzjon relattiv għar-referenza
English: Study IV (ORAL Scan)
Maltese: IV (ORAL Scan)
English: PASI75g Month 3
Maltese: PASI75g Xahar 3
English: Study V (ORAL Step)
Maltese: Studju V (ORAL Step)
English: Month 6: mTSS ACR70
Maltese: Xahar 6: mTSS ACR70
English: CYP3A & CYP2C19 Inhibitor Fluconazole
Maltese: Inibitur ta' CYP3A u CYP2C19 Fluconazole
English: CYP3A Inhibitor Ketoconazole
Maltese: Inibitur ta' CYP3A Ketoconazole
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Maltese: - Is-sustanzi l-oħra fil-pillola huma microcrystalline cellulose, lactose monohydrate (ara sezzjoni 2), croscarmellose sodium, magnesium stearate, hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), u FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
English: ≥1/10,000 to
Maltese: ≥1/10,000 sa
English: At month 12 in OCTAVE Open, 52% (25/48) and 45% (37/83) of these patients achieved remission, respectively.
Maltese: F'xahar 12 f'OCTAVE Miftuħ, 52% (25/48) u 45% (37/83) ta' dawn il pazjenti kisbu remissjoni, rispettivament.
English: Drug hypersensitivity* Angioedema* Urticaria*
Maltese: Sensittività eċċessiva għal mediċina* Anġjoedema*
English: ≥1/1,000 to
Maltese: ≥1/1,000 sa
English: The percentages of tofacitinib-treated patients achieving ACR20, ACR50 and ACR70 responses in studies ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start, and ORAL Strategy are shown in Table 8.
Maltese: Il-perċentwali ta' pazjenti kkurati b'tofacitinib li laħqu risponsi tal-ACR20, tal-ACR50 u tal-ACR70 fi studji ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start u ORAL Strategy huma murija f'Tabella 8.
English: Each film-coated tablet contains 118.88 mg of lactose.
Maltese: Kull pillola miksija b'rita fiha 118.88 mg lactose.
English: *** p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Maltese: NA NA p<0.0001, tofacitinib kontra plaċebo + MTX, LS = least squares, N = numru ta' pazjenti, QOW = kull ġimagħtejn, NA = mhux applikabbli, HAQ-DI = Health Assessment Questionnaire Disability Index
English: c OPAL BEYOND had a duration of 6 months.
Maltese: OPAL BEYOND kellu tul ta' 6 xhur.
English: INFORMATION IN BRAILLE XELJANZ 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE XELJANZ 5 mg
English: INFORMATION IN BRAILLE XELJANZ 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE XELJANZ 10 mg
English: • persistent headaches
Maltese: • uġigħ ta' ras persistenti.
English: Table 8: Proportion (%) of Patients with an ACR Response ORAL Solo: DMARD Inadequate Responders
Maltese: Tabella 8: Proporzjon (%) ta' Pazjenti b'Rispons tal-ACR ORAL Solo: Pazjenti li Rrispondew b'mod Inadegwat għal DMARD
English: Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
Maltese: e Inkiseb sinifikat statistiku fil-familja tal-ACR (ACR50 u ACR70) f'p≤ 0.05 skont il-proċedura ta' ttestjar pass 'l isfel speċifikata minn qabel.
English: Vaccinations
Maltese: Tuberkulożi
English: Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
Maltese: Tabella 9: Numru (%) ta' Individwi li Kisbu Remissjoni DAS28-4(ESR) ta' < 2.6 f'Xhur 3 u 6
English: Population DMARD-IR DMARDIR
Maltese: DMARD-IR DMARD -IR
English: OTHER Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Maltese: OĦRAJN Tne., Tli., Erb., Ħam., Ġim., Sib., Ħad.
English: MTX N=168 Mean (SD)
Maltese: MTX N=168 Medja (SD)a
English: The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined 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), or not known (cannot be estimated from the available data).
Maltese: L-ADRs elenkati f'din it-tabella hawn taħt huma minn studji kliniċi b'RA, PsA, u UC u huma ppreżentati permezz tas-Sistema tal-Klassifika tal-Organi u l-kategoriji ta' frekwenza, iddefiniti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Each film-coated tablet contains 59.44 mg of lactose.
Maltese: Kull pillola miksija b'rita fiha 59.44 mg ta' lactose.
English: g. N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
Maltese: N=101 għall-plaċebo, N=101 għal tofacitinib 5 mg darbtejn kuljum, N=87 għal tofacitinib
English: Lab Value (cells/mm3)
Maltese: (ċelluli/mm3)
English: In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
Maltese: 60.3 avveniment għal kull 100 sena tal-pazjent (li involviet 49.4% tal-pazjenti; total ta' 572 pazjent).
English: improvement, NA=not applicable, MTX=methotrexate.
Maltese: MTX=methotrexate.
English: mTSS
Maltese: mTSSc
English: Patients in the Phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Maltese: Il-pazjenti fl-istudji tal-Fażi 3 kellhom Punteġġ tal-Attività tal-Marda (DAS28-4[ESR]) ta' 6.1-6.7 fil linja bażi.
English: Meningitis cryptococcal Mycobacterium avium complex infection
Maltese: Infezzjoni kumplessa mycobacter ium avium
English: a SD = Standard Deviation b Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval) c Month 6 and month 12 data are mean change from baseline d Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Maltese: SD=Devjazzjoni Standard b Differenza bejn il-least squares means ta' tofacitinib minus plaċebo (95% CI=95% intervall ta' kunfidenza)
English: Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a
Maltese: Tofacitinib 5 mg Darbtejn Kuljum + MTX N=277 Medja (SD)a
English: In OPAL BEYOND, MDA was achieved by 22.9% and 14.5% of tofacitinib 5 mg BID and placebo treated patients, respectively, however tofacitinib 5 mg BID did not achieve nominal statistical significance (treatment difference from placebo 8.4% [95% CI: -1.0, 17.8] at month 3).
Maltese: MDA nkisbet minn 22.9% u 14.5% tal-pazjenti kkurati b'tofacitinib 5 mg BID u plaċebo, rispettivament, madankollu tofacitinib 5 mg BID ma kisbux sinifikanza statistikament nominali (differenza fil-kura minn plaċebo 8.4% [95% CI: -1.0, 17.8] f'xahar 3).
English: *p<0.05 **p<0.001 ***p<0.0001 verses placebo (versus MTX for ORAL Start) ǂp<0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
Maltese: ǂp<0.05 - tofacitinib 5 mg + MTX kontra tofacitinib 5 mg għal ORAL Strategy (valuri p normali mingħajr aġġustament ta'
English: Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Maltese: antagonisti ta' interleukin (IL)-1R, antagonisti ta' IL-6R, antikorpi monoklonali kontra CD20, antagonisti ta' IL-17, antagonisti ta' IL-12/IL-23, antiintegrini, modulaturi selettivi ta' aktar minn stimulu wieħed u immunosuppressanti qawwija bħal azathioprine, 6-mercaptopurine, ciclosporine u tacrolimus minħabba l-possibbiltà ta' żieda fl-immunosuppressjoni u żieda fir-riskju tal-infezzjoni.
English: Normalization of endoscopic appearance of the mucosac
Maltese: Normalizzazzjoni tad-dehra endoskopika tal mukużac
English: Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4)
Maltese: Tabella 3:Valur tal-Emoglobina Baxx Valur tal-Emoglobina Baxx (Sezzjoni 4.4)
English: Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a
Maltese: Tofacitinib 10 mg Darbtejn Kuljum N=368 Medja (SD)a
English: * p<0.0001; † p<0.001; ‡ p<0.05.
Maltese: *p<0.05, **p<0.
English: QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70%
Maltese: QOW=kull ġimagħtejn, N=numru ta' individwi analizzati, ACR20/50/70=titjib ta' ≥20%, 50%, 70% talKulleġġ Amerikan tar-Rewmatoloġija, NA=mhux applikabbli;
English: Placebo Placebo Placebo Placebo Placebo MTX
Maltese: Plaċebo Plaċebo Plaċebo Plaċebo Plaċebo MTX MTX,
English: In patients with RA, treatment up to 6 months with tofacitinib was associated with dose-dependent reductions of circulating CD16/56+ natural killer (NK) cells, with estimated maximum reductions occurring at approximately 8-10 weeks after initiation of therapy.
Maltese: ċelluli natual killer (NK) CD16/56+ li jiċċirkolaw, bi tnaqqis massimu stmat li jseħħ f'bejn wieħed u ieħor 8-10 ġimgħat wara l-bidu tat-terapija.
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2, and is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Maltese: In vitro, tofacitinib huwa sottostrat għal MDR1, iżda mhux għall-proteina ta' reżistenza għall-kanċer tas-sider (BCRP, breast cancer resistance protein), OATP1B1/1B3, jew OCT1/2, u mhuwiex inibitur ta' MDR1, OATP1B1/1B3,
English: In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Maltese: Studji dwar il-vaċċini Fi prova klinika kkontrollata ta' pazjenti b'RA li jibdew tofacitinib 10 mg darbtejn kuljum jew il plaċebo, in-numru ta' dawk li rrispondew għall-vaċċin tal-influwenza kien simili fiż-żewġ gruppi: tofacitinib (57%) u plaċebo (62%).
English: Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Maltese: Kull pakkett fih 56, 112 jew 182 pillola u kull flixkun fih 60 jew 180 pillola.
English: Table 13: Change From Baseline in HAQ-DI in PsA Studies OPAL BROADEN and OPAL BEYOND
Maltese: Tabella 13: Bidla Mil-Linja bażi f'HAQ-DI fi Studji dwar PsA OPAL BROADEN u OPAL
English: OCTAVE Induction Study 2 Central Endoscopy Read
Maltese: OCTAVE Studju ta' Induzzjoni 2 Qari tal-Endoskopija Ċentrali Qari tal-Endoskopija Lokali
English: Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a
Maltese: Tofacitinib 5 mg Darbtejn Kuljum N=344 Medja (SD)a
English: Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo in physical component summary (PCS) and mental component summary (MCS) scores, and in all 8 domains of the SF-36 in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2).
Maltese: Tofacitinib 10 mg darbtejn kuljum wera titjib ikbar mil-linja bażi meta mqabbel mal-plaċebo fil punteġġi tas-sommarju tal-komponent fiżiku (PCS, physical component summary) u s-sommarju tal komponent mentali (MCS, mental component summary), u fit-8 dominji kollha tas-SF-36 fl-istudji ta' induzzjoni (OCTAVE Induzzjoni 1, OCTAVE Induzzjoni 2).
English: f For patients with Baseline score > 0.
Maltese: f Għal pazjenti b'punteġġ fil-Linja bażi > 0.
English: There were no confirmed decreases in ANC below 500 cells/mm3 observed in any treatment group.
Maltese: Ma kienx hemm tnaqqis ikkonfermat fl-ANC taħt 500 ċellula/mm3 osservat fi kwalunkwe grupp tal-kura.