FrancophonIA/ELRC3.0 huggingface dataset:
English: Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity (see section 5.1).
Maltese: Vedolizumab huwa antagonist ta' integrin selettiv għall-musrana bl-ebda attività immunosoppressiva sistemika identifikata (ara sezzjoni 5.1).
English: Table 2 shows the results from the primary and secondary endpoints evaluated.
Maltese: Tabella 2 turi r-riżultati tal-punti finali primarji u sekondarji evalwati.
English: Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus.
Maltese: Xi antagonisti ta' integrin u xi sustanzi immunosoppressivi sistemiċi ġew assoċjati ma' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy), li hija infezzjoni opportunistika rari u ħafna drabi fatali kkawżata mill-virus John Cunningham (JC).
English: Clinical remission
Maltese: Remissjoni klinika
English: Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) (see section 4.4).
Maltese: Infezzjonijiet attivi severi bħal tuberkulosi (TB), sepsi, ċitomegalovirus, listerosi, u infezzjonijiet opportunistiċi bħal Lewkoenċefalopatija Multifokali Progressiva (PML - Progressive Multifocal
English: Population pharmacokinetic analyses indicate that the distribution volume of vedolizumab is approximately 5 litres.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tindika li l-volum ta' distribuzzjoni ta' vedolizumab huwa madwar 5 litri.
English: The recommended dose is 300 mg of Entyvio given as follows (see table below):
Maltese: Id-doża rakkomandata hija 300 mg ta' Entyvio mogħtija kif ġej (ara t-tabella taħt):
English: Table 3 shows the results from the primary and secondary endpoints evaluated.
Maltese: Tabella 3 turi r-riżultati tal-punti finali primarji u sekondarji evalwati.
English: GEMINI II Study Clinical remission, week 6 Overall
Maltese: Studju GEMINI II Remissjoni klinika, ġimgħa 6 Globali
English: Clinical remission, week 10 Overall
Maltese: Remissjoni klinika, ġimgħa 10 Globali
English: Do not hold1
Maltese: Iżżommx1
English: trafficking into the CNS as evidenced by the lack of change in the ratio of CD4 +/CD8
Maltese: bidla fil-proporzjon ta' CD4 +/CD8
English: Date of first authorisation: 22 May 2014 Date of latest renewal: 12 December 2018
Maltese: Data tal-aħħar tiġdid: 12 ta 'Diċembru 2018 10.
English: • anal infection
Maltese: • infezzjoni anali
English: Vedolizumab did not affect immune responses to antigenic challenge in the dermis and muscle (see section 4.4).
Maltese: Vedolizumab m'affettwax risponsi immuni għal sfida antiġenika fid dermis u fil-muskoli (ara sezzjoni 4.4).
English: Serum CRP change from baseline to week 6, median (mcg/mL) Overall‡
Maltese: Bidla ta' CRP fis-serum mil-linja bażi sa ġimgħa 6, medjan (mcg/mL) Globali‡
English: Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
Maltese: Immedjatament iġbed 5 mL (300 mg) ta' Entyvio rikostitwit permezz ta' siringa b'labra bi ħxuna ta'21-25.
English: GEMINI III Study Clinical remission, week 6 Overall‡
Maltese: Studju GEMINI III Remissjoni klinika, ġimgħa 6 Globali‡
English: There are no data on the effects of vedolizumab on human fertility.
Maltese: Fertilità M'hemmx dejta dwar l-effetti ta' vedolizumab fuq il-fertilità umana.
English: In patients with ulcerative colitis, mean steady-state serum trough concentrations were 11.2 mcg/mL (SD ± 7.24) and 38.3 mcg/mL (SD ± 24.43), respectively.
Maltese: il-konċentrazzjonijiet medji l-aktar baxxi fi stat fiss fis-serum kienu ta' 11.2 mcg/mL (SD ± 7.24) u 38.3 mcg/mL (SD ± 24.43), rispettivament.
English: Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered in clinical trials.
Maltese: Dożi sa 10 mg/kg (madwar 2.5 darbiet id-doża rakkomandata) ingħataw fi provi kliniċi.
English: Study Endpoint
Maltese: Studju Punt Finali
English: : +30 210 6387800 gr.info@takeda.com
Maltese: Τηλ.: +30 210 6387800 gr.info@takeda.com
English: Bronchitis, Gastroenteritis, Upper respiratory tract infection, Influenza, Sinusitis, Pharyngitis
Maltese: Bronkite, Gastroenterite, Infezzjoni fl-apparat respiratorju ta' fuq,
English: Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or the TNFα antagonist infliximab (including primary non-responders).
Maltese: Pazjenti rreġistrati kienu fallew mill-inqas terapija konvenzjonali waħda, inkluż kortikosterojdi, immunomodulaturi, u/jew l-antagonist ta' TNFα infliximab (inkluż pazjenti li ma rrispondewx primarjament).
English: Enhanced clinical response was achieved in 29%, 38%, 21%, respectively, and corticosteriod-free clinical remission was achieved in 24%, 16%, 0%, respectively.
Maltese: Rispons kliniku msaħħaħ intlaħaq f'29%, 38%, 21%, rispettivament, u remissjoni klinika mingħajr kortikosterojdi inkisbet f'24%, 16%, 0%, rispettivament.
English: Corticosteroid-free clinical remission♠
Maltese: Remissjoni klinika mingħajr kortikosterojdi♠
English: Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection
Maltese: Soluzzjoni dilwita f'soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni
English: Takeda Austria GmbH St. Peter-Straße 25 4020 Linz
Maltese: Peter-Straβe 25 A-4020
English: Improvements in durable clinical response (47%, 43%, 16%), mucosal healing (42%, 48%, 8%), durable clinical remission (21%, 13%, 3%) and corticosteroid-free clinical remission (23%, 32%, 4%) were seen in the prior TNFα antagonist failure population treated with vedolizumab every eight weeks, vedolizumab every four weeks and placebo, respectively.
Maltese: Titjib fir-rispons kliniku li jdum (47%, 43%, 16%), fejqan tal-mukuża (42%, 48%, 8%), remissjoni klinika li ddum (21%, 13%, 3%) u remissjoni klinika mingħajr kortikosterojdi (23%, 32%,
English: It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes.
Maltese: Huwa antikorp monoklonali umanizzat li jeħel speċifikament mal integrin α4β7, li huwa preżenti b'mod preferenzjali fuq limfoċiti T helper li jfittxu l-musrana.
English: In GEMINI III at week 6 and 10 the respective clinical remission rates were 18% (difference from placebo 3%, 95% CI: -7, 13) and 22% (difference from placebo 8%, 95% CI: -3, 19) when administered without corticosteroids compared to 20% (difference from placebo 11%, 95% CI: 2, 20) and 35% (difference from placebo 23%, 95% CI: 12, 33) respectively when administered with concomitant corticosteroids.
Maltese: F'GEMINI III f'ġimgħa 6 u 10 ir-rati ta' remissjoni klinika rispettivi kienu ta' 18% (differenza mill-plaċebo ta' 3%, CI ta' 95%: -7, 13) u 22% (differenza mill-plaċebo ta' 8%, CI ta' 95%: -3, 19 )
English: Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Maltese: IgG1 umanizzat li jeħel ma' integrin α4β7uman u huwa magħmul bl-użu ta' teknoloġija tad-DNA rikombinanti f'ċelluli tal-ovarju tal-ħamster Ċiniż (CHO - Chinese hamster ovary).
English: Vedolizumab did not affect immune surveillance and inflammation of the central nervous system in Experimental Autoimmune Encephalomyelitis in non-human primates, a model of multiple sclerosis.
Maltese: Vedolizumab ma affettwax is-sorveljanza immuni u l-infjammazzjoni tas-sistema nervuża ċentrali f'Enċefalomijelite Awtoimmuni Sperimentali (Experimental Autoimmune Encephalomyelitis) fi primati mhux umani, mudell ta' sklerożi multipla.
English: Vedolizumab has been studied in adult ulcerative colitis and Crohn's disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and aminosalicylates.
Maltese: Vedolizumab kien studjat f'pazjenti adulti li għandhom kolite ulċerattiva u l-marda ta' Crohn bl-għoti fl-istess waqt ta' kortikosterojdi, immunomodulaturi (azathioprine, 6-mercaptopurine, u methotrexate),
English: In contrast, vedolizumab inhibited an immune response to a gastrointestinal antigenic challenge in healthy human volunteers (see section 4.4).
Maltese: B'kuntrast, vedolizumab inibixxa rispons immuni għal sfida antiġenika gastrointestinali f'voluntiera umani f'saħħithom (ara sezzjoni 4.4).
English: • redness and tenderness of hair follicle
Maltese: • ħmura u sensittività ta' follikulu tax-xagħar
English: Entyvio is administered as an intravenous infusion over 30 minutes.
Maltese: Entyvio jingħata bħala infużjoni fil-vini fuq medda ta' 30 minuta.
English: • moderately to severely active ulcerative colitis
Maltese: • kolite ulċerattiva attiva b'mod moderat sa sever
English: • blurred vision (loss of sharpness of eyesight)
Maltese: • vista mċajpra (telf taċ-ċarezza tal-vista)
English: Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs).
Maltese: Vedolizumab jagħmel parti minn grupp ta' mediċini bijoloġiċi msejħa antikorpi monoklonali (MAbs - monoclonal antibodies).
English: Add the 5 mL (300 mg) of reconstituted Entyvio to 250 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection, and gently mix the infusion bag (5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection does not have to be withdrawn from the infusion bag prior to adding Entyvio).
Maltese: Żid il-5 mL (300 mg) ta' Entyvio rikostitwit ma' 250 mL ta' soluzzjoni sterili ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni, u bil-mod ħawwad il-borża tal-infużjoni (m'hemmx għalfejn jitneħħa 5 mL ta' soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni mill-borża tal-infużjoni qabel jiżdied Entyvio).
English: In patients with Crohn's disease mean steady-state serum trough concentrations were 13.0 mcg/mL (SD ± 9.08) and 34.8 mcg/mL (SD ± 22.55), respectively.
Maltese: F'pazjenti bil-marda ta' Crohn, il-konċentrazzjonijiet medji l-aktar baxxi fi stat fiss fis-serum kienu ta' 13.0 mcg/mL (SD ± 9.08) u 34.8 mcg/mL (SD ± 22.55), rispettivament.
English: Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Maltese: Analiżi farmakokinetika tal-popolazzjoni ma wriet l-ebda effett tal-età (ara sezzjoni 5.2).
English: The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopic sub score ≥ 2) was demonstrated in a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52 (GEMINI I).
Maltese: L-effikaċja u s-sigurtà ta' vedolizumab għall-kura ta' pazjenti adulti b'kolite ulċerattiva b'attività moderata sa severa (punteġġ Mayo ta' 6 sa 12 b'sottopunteġġ endoskopiku ta' ≥ 2) intwerew fi studju randomised, double-blind u kkontrollat bil-plaċebo li evalwa l-punti finali tal-effikaċja f'ġimgħa 6 u ġimgħa 52 (GEMINI I).
English: §Clinical remission: Complete Mayo score of ≤ 2 points and no individual subscore > 1 point
Maltese: Punteġġ Mayo komplut ta' ≤2 punti u l-ebda sottopunteġġ individwali ta' > 1 punt
English: Storage Condition Refrigerator (2°C-8°C)
Maltese: Fil-friġġ (2 °C-8 °C)
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala' u treddigħ Nisa li jistgħu joħorġu tqal
English: In healthy subjects, ulcerative colitis patients, or Crohn's disease patients, vedolizumab does not elevate neutrophils, basophils, eosinophils, B-helper and cytotoxic T lymphocytes, total memory T helper lymphocytes, monocytes or natural killer cells, in the peripheral blood with no leukocytosis observed.
Maltese: F'individwi f'saħħithom, pazjenti b'kolite ulċerattiva, jew pazjenti bil marda ta' Crohn, vedolizumab ma jelevax newtrofili, bażofili, eosinofili, limfoċiti B-helper u limfoċiti T ċitotossiċi, limfoċiti T helper ta' memorja totali, monoċiti jew natural killer cells, fid-demm periferali u ma kienet osservata l-ebda lewkoċitosi.
English: The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220 to 450) were evaluated in two studies (GEMINI II and III).
Maltese: L-effikaċja u s-sigurtà ta' vedolizumab għall-kura ta' pazjenti adulti b'marda ta' Crohn attiva b'mod moderat sa sever (punteġġ tal-Indiċi tal-Attività tal-Marda ta' Crohn [CDAI - Crohn's Disease Activity Index] ta' 220 sa 450) kienu evalwati f'żewġ studji (GEMINI II u III).
English: The α4β7 integrin is expressed on a discrete subset of memory T helper lymphocytes which preferentially migrate into the gastrointestinal (GI) tract and cause inflammation that is characteristic of ulcerative colitis and Crohn's disease, both of which are chronic inflammatory immunologically mediated conditions of the GI tract.
Maltese: L-integrin α4β7 huwa preżenti fuq sottosett diskret ta' limfoċiti T helper ta' memorja li preferenzjalment jemigraw fl-apparat gastrointestinali (GI - gastrointestinal) u jikkawżaw infjammazzjoni li hija karatteristika ta' kolite ulċerattiva u tal-marda ta' Crohn, li t-tnejn huma kondizzjonijiet kroniċi infjammatorji medjati b'mod immunoloġiku tal-apparat GI.
English: Patients (n = 368) were randomised in a double-blind fashion (3:2) to receive two doses of vedolizumab 300 mg or placebo at week 0 and week 2.
Maltese: Il-pazjenti (n = 368) kienu randomised b'mod double-blind (3:2) biex jirċievu żewġ dożi ta' vedolizumab 300 mg jew plaċebo f'ġimgħa 0 u ġimgħa 2.
English: Scientific conclusions
Maltese: Punt Finali
English: The GEMINI II Study was a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52.
Maltese: L-Istudju GEMINI II kien studju randomised, double-blind u kkontrollat bil-plaċebo li evalwa l-punti finali tal-effikaċja f'ġimgħa 6 u ġimgħa 52.
English: • hives
Maltese: • murliti
English: Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection can be stored up to 12 hours at a room temperature of not above 25 °C, or up to 24 hours in a refrigerator (2 °C-8 °C), or for up to 12 hours at room temperature and in a refrigerator (2 °C-8 °C), up to a combined total of 24 hours.
Maltese: Is-soluzzjoni dilwita f'soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni tista' tinħażen sa 12-il siegħa f'temperatura ambjentali ta' mhux aktar minn 25 ˚C, jew sa 24 siegħa fi friġġ (2 ˚C-8 ˚C), jew sa 12-il siegħa fit-temperatura tal-kamra u fi friġġ (2 ˚C-8 ˚C) sa total kombinat ta' 24 siegħa.
English: Vedolizumab exhibited linear pharmacokinetics at serum concentrations greater than 1 mcg/mL.
Maltese: Vedolizumab wera farmakokinetika lineari f'konċentrazzjonijiet fis serum ogħla minn 1 mcg/mL.
English: ¶Durable clinical remission: Clinical remission at ≥ 80% of study visits including final visit (week 52)
Maltese: Remissjoni klinika f'≥ 80% tal-visti tal-istudju inkluż il-vista finali (ġimgħa 52)
English: Primary endpoint was the proportion of patients in clinical remission at week 52 (see Table 5).
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti f'remissjoni klinika f'ġimgħa 52 (ara Tabella 5).
English: Efficacy Results for GEMINI II at week 52 Placebo n = 153*
Maltese: Riżultati tal-Effikaċja għal GEMINI II f'ġimgħa 52 Plaċebo
English: Sustained clinical remission#,¶ Overall
Maltese: Remissjoni klinika sostnuta#¶
English: Enhanced clinical response was observed at week 10 and week 14 for greater proportions of vedolizumab patients 16% and 22%, respectively, compared with placebo patients 7% and 12%, respectively.
Maltese: Rispons kliniku msaħħaħ kien osservata f'ġimgħa 10 u ġimgħa 14 għall-proporzjonijiet akbar ta' pazjenti fuq vedolizumab 16% u 22%, rispettivament, meta mqabbel ma' pazjenti fuq plaċebo 7% u 12%, rispettivament.
English: De uts chland Takeda GmbH Tel.: +49 (0) 800 825 3325 medinfo@takeda.de
Maltese: +49 (0) 800 825 3325 medinfo@takeda.de
English: In GEMINI II,
Maltese: ANNESS II
English: TNFα Antagonist(s) Failure¶
Maltese: Falliment ta' Antagonist(i) ta' TNFα
English: These data are consistent with investigations in nonhuman primates which did not detect effects on immune surveillance of the CNS.
Maltese: Din id-dejta hija konsistenti ma' investigazzjonijiet fi primati mhux umani li ma osservawx effetti fuq is-sorveljenza immuni tas-CNS.
English: Takeda Nederland bv Tel.: +31 23 56 68 777 nl.medical.info@takeda.com
Maltese: +31 23 56 68 777 nl.medical.info@takeda.com
English: • chest infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: TNFα Antagonist(s) Failure¶,‡
Maltese: Falliment ta' Antagonist(i) ta' TNFα¶
English: In controlled and open-label studies in adults with vedolizumab, serious infections have been reported, which include tuberculosis, sepsis (some fatal), salmonella sepsis, listeria meningitis, and cytomegaloviral colitis.
Maltese: Fi studji kkontrollati u open-label b'vedolizumab fl-adulti, kienu rrappurtati infezzjonijiet serji, li jinkludu tuberkulożi, sepsi (uħud fatali), sepsi kkawżat minn salmonella, meninġite kkawżata minn listeria, u kolite kkawżata minn ċitomegalovirus.
English: The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' vedolizumab fit-tfal minn età ta' 0 sa 17-il sena għadhom ma ġewx determinati s'issa.
English: Given the lack of binding of vedolizumab to male reproductive tissue in monkey and human, and the intact male fertility observed in β7 integrin-knockout mice, it is not expected that vedolizumab will affect male fertility.
Maltese: Minħabba n-nuqqas ta' rbit ta' vedolizumab mat tessut riproduttiv maskili fix-xadini u l-bnedmin, u l-fertilità maskili intatta osservata fi ġrieden b'integrin β7 nieqes, mhux mistenni li vedolizumab jaffettwa l-fertilità maskili.
English: Patient numbers were n = 72 for placebo, n = 70 for vedolizumab every eight weeks, and n = 73 for vedolizumab every four weeks
Maltese: pazjenti kien n = 72 għall-plaċebo, n = 70 għal vedolizumab kull tmien ġimgħat, u n = 73 għal vedolizumab kull erba' ġimgħat
English: Inhibiting the interaction of α4β7 with MAdCAM-1 with vedolizumab prevents transmigration of gut-homing memory T helper lymphocytes across the vascular endothelium into parenchymal tissue in nonhuman primates and induced a reversible 3-fold elevation of these cells in peripheral blood.
Maltese: L-inibizzjoni tal-interazzjoni ta' α4β7 ma' MAdCAM-1 b'vedolizumab tipprevjeni t-transmigrazzjoni ta' limfoċiti T helper ta' memorja li jfittxu l-musrana minn ġol-endotelju vaskulari għat-tessut parenkimali fi primati mhux umani u induċiet elevazzjoni riversibbli ta' 3 darbiet ta' dawn iċ-ċelluli fid demm periferali.
English: Vedolizumab is a gut-selective immunosuppressive biologic.
Maltese: Vedolizumab huwa immunosoppressiv bijoloġiku selettiv għall musrana.
English: Takeda, UAB Tel.: +370 521 09 070 It-info@takeda.com
Maltese: +370 521 09 070 it-info@takeda.com
English: Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Maltese: Entyvio huwa indikat għall-kura ta' pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever li kellhom rispons inadegwat, ma baqgħux jirrispondu, jew kienu intolleranti għal terapija konvenzjonali jew għall-antagonist tal-fattur tan-nekrosi tat-tumur alpha (TNFα - tumour necrosis factor-alpha).
English: Takeda Pharma AS Tel.: +372 6177 669 info@takeda.ee
Maltese: +372 6177 669 info@takeda.ee
English: Vedolizumab reduces gastrointestinal inflammation in UC and CD patients.
Maltese: Ma kienet osservata l-ebda tossiċità li tillimita id-doża fil-provi kliniċi.
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection, bronchitis, influenza and sinusitis), headache, nausea, pyrexia, fatigue, cough, arthralgia.
Maltese: L­aktar reazzjonijiet avversi li gew irrappurtati b'mod komuni huma infezzjonijiet (bħal nasofarinġite, infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja, bronkite, influwenza u sinożite), uġigħ ta' ras, tqalligħ, deni, għeja, sogħla u artralġja.
English: Remove flip-off cap from the vial and wipe with alcohol swab.
Maltese: Neħħi l-għatu flip off mill-kunjett u imsaħ b'imselħa tal-alkoħol.
English: Patients (n = 416), which included approximately 75% TNFα antagonist failures patients, were randomised in a double-blind fashion (1:1) to receive either vedolizumab 300 mg or placebo at weeks 0, 2, and 6.
Maltese: Il-pazjenti (n = 416), li kienu jinkludu madwar 75% tal-pazjenti li ma rrispondewx għal antagonist ta' TNFα, kienu randomised b'mod double-blind (1:1) biex jirċievu vedolizumab 300 mg jew plaċebo f'ġimgħat 0, 2, u 6.
English: Respiratory tract infection, Vulvovaginal candidiasis, Oral candidiasis, Herpes zoster
Maltese: Kandidajasi orali, Herpes zoster
English: Week 6 Efficacy Results of GEMINI I
Maltese: Riżultati tal-Effikaċja f'Ġimgħa 6 ta' GEMINI I
English: Exploratory analyses provide additional data on key subpopulations studied.
Maltese: Analiżi esploratorja ipprovdiet dejta addizzjonali dwar is sottopopolazzjonijiet prinċipali studjati.
English: Health-related quality of life (HRQOL) was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), a disease specific instrument, and SF-36 and EQ-5D, which are general measures.
Maltese: Questionnaire), strument speċifiku għall-marda, u SF-36 u EQ-5D, li huma miżuri ġenerali.
English: No formal studies have been conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of vedolizumab.
Maltese: Ma sarux studji formali biex jiġu eżaminati l-effetti ta' indeboliment renali jew epatiku fuq il-farmakokinetika ta' vedolizumab.
English: in cerebrospinal fluid pre- and post-vedolizumab administration in healthy human volunteers.
Maltese: fil-fluwidu ċerebrospinali qabel u wara l-għoti ta' -vedolizumab f'voluntiera umani f'saħħithom.
English: In a pharmacologically responsive species (cynomolgus monkeys), there was no evidence of cellular hyperplasia or systemic immunomodulation that could potentially be associated with oncogenesis in 13- and 26-week toxicology studies.
Maltese: Fi speċi b'rispons farmakoloġiku (xadini cynomolgus), ma kienx hemm evidenza ta' iperplażja ċellulari jew ta' immunomodulazzjoni sistemika li potenzjalment jistgħu jkunu assoċjati ma onkoġenesi fi studji dwar l effett tossiku li damu 13 u 26 ġimgħa.
English: In these patients, clinical remission was achieved in 25% of patients at week 28 and week 52.
Maltese: remissjoni klinika inkiseb f'25% tal-pazjenti f'ġimgħa 28 u ġimgħa 52.
English: M anufacture r Delpharm Novara S.r.l.
Maltese: Manifattur Delpharm Novara S.r.l. Via Crosa, 86
English: Based on plausible mechanism and available number of spontaneous reports of herpes zoster, the PRAC concluded that the product information should be updated with herpes zoster as a new adverse drug reaction with frequency uncommon.
Maltese: Ibbażat fuq mekkaniżmu plawsibbli u fuq n-numru disponibbli ta' rapporti spontanji ta' herpes zoster, il-PRAC ikkonkluda li l-informazzjoni dwar il-prodott għandha tiġi aġġornata b'herpes zoster bħala reazzjoni avversa ġdida tal-mediċina b'frekwenza mhux komuni.
English: Clinical response using partial Mayo scores was achieved at week 10 and week 14 by greater proportions of vedolizumab patients (32% and 39%, respectively) compared with placebo patients (15% and 21%, respectively).
Maltese: Rispons kliniku bl-użu tal-punteġġi parzjali Mayo intlaħaq f'ġimgħa 10 u ġimgħa 14 minn proporzjonijiet akbar ta' pazjenti fuq vedolizumab (32% u 39%, rispettivament) meta mqabbla ma'