FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical remission rate in GEMINI II at week 6 was 10% (difference from placebo 2%, 95% CI: -6, 10) when administered without corticosteroids compared to 20% (difference from placebo 14%, 95% CI: -1, 29) when administered with concomitant corticosteroids.
Maltese: Ir-rata ta' remissjoni klinika f'GEMINI II f'ġimgħa 6 kienet ta' 10% (differenza mill-plaċebo ta' 2%, CI ta' 95%: -6, 10) meta jingħata mingħajr kortikosterojdi meta mqabbel ma'
English: • tiredness
Maltese: • ħorriqija
English: Reconstitute vedolizumab with 4.8 mL of sterile water for injections at room temperature (20 °C-25 °C), using a syringe with a 21-25 gauge needle.
Maltese: Irrikostitwixxi vedolizumab b'4.8 mL ta' ilma għall-injezzjonijiet sterili fit-temperatura tal-kamra (20 °C-25
English: The combined in-use stability of Entyvio in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.
Maltese: L-istabbiltà kombinata waqt l-użu ta' Entyvio fil-kunjett u l-borża tal-infużjoni ma' soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni hi total ta' 12-il siegħa f'temperatura ta' 20 °C-25
English: • stomach flu
Maltese: • infezzjoni fil-griżmejn
English: Vedolizumab Every 8 weeks n = 154
Maltese: ¶n = 157 għall-plaċebo u n = 158 għal vedolizumab
English: The two primary endpoints were the proportion of patients in clinical remission (defined as CDAI score ≤ 150 points) at week 6 and the proportion of patients with enhanced clinical response (defined as a ≥ 100-point decrease in CDAI score from baseline) at week 6 (see Table 4).
Maltese: Iż-żewġ punti finali primarji kienu l-proporzjon ta' pazjenti f'remissjoni klinika (definita bħala punteġġ ta' CDAI ta' ≤ 150 punt) f'ġimgħa 6 u l proporzjon ta' pazjenti b'rispons kliniku msaħħaħ (definit bħala tnaqqis ta' ≥ 100 punt fil-punteġġ ta' CDAI mil-linja bażi) f'ġimgħa 6 (ara
English: Adverse Reactions System Organ Class
Maltese: Klassi tas-Sistemi u tal-Organi Frekwenza
English: Patient numbers were n = 82 for placebo, n = 82 for vedolizumab every eight weeks, and n = 80 for vedolizumab every four weeks
Maltese: pazjenti kien n = 82 għall-plaċebo, n = 82 għal vedolizumab kull tmien ġimgħat, u n = 80 għal vedolizumab kull erba' ġimgħat
English: Furthermore, no effects were found of vedolizumab on the proliferative rate or cytotoxicity of a human tumour cell line expressing the α4β7 integrin in vitro.
Maltese: Barra dan, ma kinux osservati effetti ta' vedolizumab fuq ir-rata proliferattiva jew fuq iċ-ċitotossiċità ta' linja ta' ċelluli ta' tumur uman li tesprimi l-integrin α4β7 in vitro.
English: Mucosal healing Durable clinical remission#
Maltese: Rispons kliniku Remissjoni klinika§
English: Concomitant stable doses of oral corticosteroids, immunomodulators, and antibiotics were permitted.
Maltese: Kienu permessi dożi stabbli fl-istess waqt ta' kortikosterojdi, immunomodulaturi u antibijotiċi orali.
English: GEMINI II contained two cohorts of patients that received vedolizumab at weeks 0 and 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 461 patients from cohorts 1 and 2, who were treated with vedolizumab and had achieved clinical response (defined as a ≥ 70-point decrease in CDAI score from baseline) at week 6, were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
Maltese: Biex tiġi evalwata l-effikaċja f'ġimgħa 52, 461 pazjent minn ko-orti 1 u 2 li kienu kkurati b'vedolizumab u kienu kisbu rispons kliniku (definit bħala tnaqqis ta' ≥ 70 punt fil-punteġġ ta' CDAI mil-linja bażi) f'ġimgħa 6, kienu randomised b'mod double-blind (1:1:1) għal wieħed mill-korsijiet li ġejjin b'bidu f'ġimgħa 6:
English: Each vial contains 300 mg of vedolizumab.
Maltese: Kull kunjett fih 300 mg ta' vedolizumab.
English: Vedolizumab did not affect CD4
Maltese: Vedolizumab ma affettwax il-passaġġ ta' CD4
English: In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity (see section 4.8).
Maltese: Fi studji kliniċi, kienu rrappurtati reazzjonijiet relatati mal-infużjoni (IRR - infusion-related reactions) u reazzjonijiet ta' sensittività eċċessiva, li l-maġġoranza tagħhom kienu ħfief sa moderati fis-severità tagħhom (ara sezzjoni 4.8).
English: In this open-label extension study, the benefits of vedolizumab treatment as assessed by partial Mayo score, clinical remission, and clinical response were shown for up to 196 weeks.
Maltese: F'dan l-istudju ta' estensjoni open-label, il-benefiċċji ta' kura b'vedolizumab kif evalwat mill-punteġġ parzjali Mayo, remissjoni klinika, u rispons kliniku intwerew għal sa 196 ġimgħa.
English: Treatment 1
Maltese: Kura 1
English: NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Maltese: IL-PRODOTT MEDIĊINALI Entyvio 300 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Population pharmacokinetic analyses suggest that while low albumin, higher body weight and prior treatment with anti-TNF drugs may increase vedolizumab clearance, the magnitude of their effects is not considered to be clinically relevant.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tissuġġerixxi li filwaqt li albumina baxxa, piż tal-ġisem ogħla u kura minn qabel b'mediċini kontra TNF jistgħu jżidu t-tneħħija ta' vedolizumab, id-daqs tal-effetti tagħhom mhux meqjus li huwa klinikament rilevanti.
English: In GEMINI I, two cohorts of patients received vedolizumab at week 0 and week 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 373 patients from cohort 1 and 2 who were treated with vedolizumab and had achieved clinical response at week 6 were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
Maltese: F'GEMINI I, żewġ ko-orti ta' pazjenti rċevew vedolizumab f'ġimgħa 0 u ġimgħa 2: pazjenti ta' ko-orti 1 kienu randomised biex jirċievu vedolizumab 300 mg jew plaċebo b'mod double-blind, u pazjenti ta' ko-orti 2 kienu kkurati b'vedolizumab 300 mg open-label.
English: In GEMINI I and II controlled studies, 4% of vedolizumab-treated patients and 3% of placebo-treated patients experienced an adverse reaction defined by the investigator as infusion-related reaction (IRR) (see section 4.4).
Maltese: Fl-istudji kkontrollati GEMINI I u II, 4% tal-pazjenti kkurati b'vedolizumab u 3% tal-pazjenti kkurati bil-plaċebo kellhom reazzjoni avversa definita mill-investigatur bħala reazzjoni relatata mal-infużjoni
English: Exploratory analyses examined the effects of concomitant corticosteroids and immunomodulators on induction of remission with vedolizumab.
Maltese: Analiżi esploratorja eżaminat l-effetti ta' kortikosterojdi u immunomodulatorji fl-istess waqt fuq l-induzzjoni ta' remissjoni b'vedolizumab.
English: Rash, Pruritus, Eczema, Erythema, Night sweats, Acne
Maltese: Dispepsja, Stitikezza, Distensjoni addominali, Gass, Murliti
English: • There is no clinical trial experience with Entyvio in patients previously treated with natalizumab.
Maltese: • M'hemmx esperjenza minn prova klinika b'Entyvio f'pazjenti kkurati minn qabel b'natalizumab.
English: One serious adverse reaction of IRR was reported in a Crohn's disease patient during the second infusion (symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.
Maltese: Reazzjoni avversa serja waħda ta' IRR kienet irrappurtata f'pazjent bil marda ta' Crohn matul it-tieni infużjoni (sintomi rrappurtati kienu qtugħ ta' nifs, bronkospażmu, urtikarja, fwawar, raxx, u żieda fil pressjoni tad-demm u fir-rata tal-qalb) u kien immaniġġjat b'suċċess permezz ta' twaqqif tal-infużjoni u kura b'antistamina u b'hydrocortisone fil-vini.
English: The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis.
Maltese: vedolizumab fil-ġrieden taffa l-infjammazzjoni gastrointestinali f'cotton-top tamarins (speċi ta' xadini żgħar) b'kolite, mudell ta' kolite ulċerattiva.
English: • haemorrhoids
Maltese: • ekżema
English: In a placebo-controlled study of healthy volunteers, a single 750 mg dose of vedolizumab did not lower rates of protective immunity to hepatitis B virus in subjects who were vaccinated intramuscularly with three doses of recombinant hepatitis B surface antigen.
Maltese: Vaċċini ħajjin u orali Fi studju kkontrollat bil-plaċebo ta' voluntiera f'saħħithom, doża waħda ta' 750 mg ta' vedolizumab ma naqqsitx ir-rati ta' immunità protettiva għall-virus tal-epatite B f'pazjenti li kienu mlaqqma fil-muskoli bi tliet dożi tas-surface antigen rikombinanti tal-epatite B.
English: In this open-label extension study, clinical remission and clinical response were observed in patients for up to 196 weeks.
Maltese: F'dan l-istudju ta' estensjoni open-label, remissjoni klinika u rispons kliniku kienu osservati f'pazjenti sa 196 ġimgħa.
English: Entyvio is not recommended for use in children or adolescents (under 18 years of age) due to the lack of information regarding the use of this medicine in this age group.
Maltese: Entyvio mhux irrakkomandat għall-użu fi tfal jew adolexxenti (b'età inqas minn 18-il sena) minħabba n-nuqqas ta' informazzjoni dwar l użu ta' din il-mediċina f'dan il-grupp ta' età.
English: including corticosteroids, immunomodulators, and/or TNFα antagonists (including primary non-responders).
Maltese: Pazjenti rreġistrati kienu fallew mill-inqas terapija konvenzjonali waħda, inkluż kortikosterojdi, immunomodulaturi, u/jew antagonisti ta' TNFα (inkluż pazjenti li ma rrispondewx primarjament).
English: Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10 (see section 5.1).
Maltese: Terapija għall-pazjenti b'kolite ulċerattiva għandha tiġi mwaqqfa jekk ma tkun osservata l-ebda evidenza ta' benefiċċju terapewtiku sa ġimgħa 10 (ara sezzjoni 5.1).
English: As noted in Table 4, although the primary endpoint was not met, exploratory analyses show that clinically meaningful results were observed.
Maltese: Il-punt finali primarju ma ntlaħaqx, l analiżi esploratorja turi li kienu osservati riżultati klinikament sinifikanti.
English: Exploratory analysis showed clinically meaningful improvements were observed for the vedolizumab every four weeks and every eight weeks groups in GEMINI II and the improvements were significantly greater as compared with the placebo group from baseline to week 52 on EQ-5D and EQ-5D VAS scores, total IBDQ score, and IBDQ subscales of bowel symptoms and systemic function.
Maltese: Analiżi esploratorja turi li kien osservat titjib klinikament sinifikanti għall-gruppi ta' vedolizumab, u t-titjib kien ogħla b'mod sinifikanti meta mqabbel mal-grupp tal-plaċebo f'ġimgħa 6 u ġimgħa 52 fuq il-punteġġi EQ-5D u EQ-5D, is-sottoskali kollha ta' IBDQ (sintomi tal-musrana, funzjoni sistemika,
English: Vedolizumab does not bind to, nor inhibit function of, the α4β1 and αEβ7 integrins.
Maltese: Vedolizumab ma jeħilx ma', u lanqas jinibixxi l-funzjoni tal-integrins α4β1 u αEβ7.
English: Week 52 Efficacy Results of GEMINI I
Maltese: Tabella 3. Riżultati tal-Effikaċja f'Ġimgħa 52 ta' GEMINI I
English: Magyarország Takeda Pharma Kft. Tel.: +361 2707030 info-hu@takeda.com
Maltese: +361 2707030 info-hu@takeda.com
English: Population pharmacokinetic analyses indicate that vedolizumab has a total body clearance of approximately 0.157 L/day and a serum half-life of 25 days.
Maltese: madwar 0.157 L/jum u half-life fis serum ta' 25 jum.
English: Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Maltese: TAL-PRODOTT MEDIĊINALI Entyvio 300 mg trab għal konċentrat għal soluzzjoni għall-infużjoni vedolizumab
English: Treatment 3
Maltese: ANNESS III
English: MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to tissues within the gastrointestinal tract.
Maltese: MAdCAM-1 fil-biċċa l-kbira hija preżenti fuq ċelluli tal-endotelju tal musrana u għandha rwol kritiku biex il-limfoċiti T isibu t-tessuti fl-apparat gastrointestinali.
English: Exploratory subgroup analyses from the clinical trials in Crohn's disease suggested that vedolizumab administered in patients without concomitant corticosteroid treatment may be less effective for induction of remission in Crohn's disease than in those patients already receiving concomitant corticosteroids (regardless of use of concomitant immunomodulators; see section 5.1).
Maltese: Analiżi esploratorja tas-sottogrupp mill-provi kliniċi fil-marda ta' Crohn tissuġġerixxi li vedolizumab mogħti lill-pazjenti mingħajr kura b'kortikosterojdi fl-istess waqt jista' jkun inqas effettiv għall-induzzjoni ta' remissjoni fil-marda ta' Crohn milli f'dawk il-pazjenti li ġa jkunu qed jirċievu kortikosterojdi fl-istess waqt (irrispettivament minn immunomodulatorji fl-istess waqt; ara sezzjoni 5.1).
English: No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Maltese: Ma tistax tittieħed konklużjoni definittiva dwar l-organi riproduttivi maskili fi studju dwar l-effett tossiku minn dożi ripetuti f'xadin cynomolgus.
English: • if you have an active severe infection, for example, tuberculosis, blood poisoning, severe gastroenteritis, nervous system infection.
Maltese: • jekk inti għandek infezzjoni severa attiva, per eżempju tuberkulożi, avvelenament tad-demm,
English: How to store Entyvio
Maltese: Mediċini oħra u Entyvio
English: Takeda Pharma AB Tel.: +46 8 731 28 00 infosweden@takeda.com
Maltese: +46 8 731 28 00 infosweden@takeda.com
English: Treatment (infusion) number
Maltese: Numru ta' kura (infużjoni)
English: In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, > 95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients.
Maltese: Fi provi kliniċi b'vedolizumab f'dożi li varjaw minn 2 sa 10 mg/kg, fil-pazjenti kienet osservata saturazzjoni ta' > 95% tar-riċetturi α4β7 fuq sottogruppi ta' limfoċiti li jiċċirkolaw involuti fis-sorveljanza immuni tal-musrana.
English: The GEMINI III Study was a second randomised, double-blind, placebo-controlled study that evaluated efficacy at week 6 and week 10 in the subgroup of patients defined as having failed at least one conventional therapy and failed TNFα antagonist therapy (including primary non-responders) as well as the overall population, which also included patients who failed at least one conventional therapy and were naïve to TNFα antagonist therapy.
Maltese: L-Istudju GEMINI III kien it-tieni studju randomised, double-blind, ikkontrollat bil-plaċebo li evalwa l-effikaċja f'ġimgħa 6 u ġimgħa 10 fis-sottogrupp ta' pazjenti definiti bħala li ma rrispondewx għal tal-inqas terapija konvenzjonali waħda u ma rrispondewx għal terapija b'antagonist ta' TNFα (inkluż dawk li primarjament ma rrispondewx) kif ukoll il-popolazzjoni globali, li kienet tinkludi wkoll pazjenti li ma rrispondewx għal mill-inqas terapija konvenzjonali waħda u qatt ma kienu ħadu terapija b'antagonist ta' TNFα.
English: In these patients, clinical remission was achieved in 45% of patients by 28 weeks and 36% of patients by 52 weeks.
Maltese: F'dawn il-pazjenti, remissjoni klinika inkisbet f'45% tal-pazjenti sa ġimgħa 28 u f'36% tal-pazjenti sa ġimgħa 52.
English: Vedolizumab blocks a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn's disease, and so the amount of inflammation is reduced.
Maltese: Vedolizumab jimblokka proteina fuq il-wiċċ ta' ċelluli bojod tad-demm li jikkawżaw l-infjammazzjoni f'kolite ulċerattiva u fil-marda ta' Crohn, u għalhekk l-infjammazzjoni tiġi mnaqqsa.
English: Store in a refrigerator (2 °C-8 °C).
Maltese: Aħżen fi friġġ (2˚C-8˚C).
English: Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn's disease 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: Marda ta' Crohn Entyvio huwa indikat għall-kura ta' pazjenti adulti bil-marda ta' Crohn 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: Vedolizumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.
Maltese: Vedolizumab huwa antikorp monoklonali terapewtiku u mhux mistenni li jeħel mal-proteini tal-plażma.
English: Age does not impact the vedolizumab clearance in ulcerative colitis and Crohn's disease patients based on the population pharmacokinetic analyses.
Maltese: L-età m'għandhiex impatt fuq it-tneħħija ta' vedolizumab f'pazjenti b'kolite ulċerattiva u bil-marda ta' Crohn bbażati fuq l-analiżi tal farmakokinetika tal-popolazzjoni.
English: Infusion related reactions after vedolizumab infusion are reported in subjects with anti-vedolizumab antibodies.
Maltese: Reazzjonijiet relatati mal-infużjoni wara l-infużjoni ta' vedolizumab huma rrappurtati f'individwi b'antikorpi anti-vedolizumab.
English: • itching / itchiness
Maltese: • tgħaddi l-gass
English: • anal sore
Maltese: • ferita anali
English: Primary endpoint was the proportion of patients in clinical remission at week 52.
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti f'remissjoni klinika f'ġimgħa 52.
English: †p < 0.0001 ‡p < 0.001 §p < 0.05 ¶Durable clinical response: Clinical response at weeks 6 and 52 #Durable clinical remission: Clinical remission at weeks 6 and 52 ♠Corticosteroid-free clinical remission: Patients using oral corticosteroids at baseline who had discontinued corticosteroids beginning at week 6 and were in clinical remission at week 52.
Maltese: §Remissjoni klinika mingħajr kortikosterojdi: Pazjenti li kienu jużaw kortikosterojdi orali fil-linja bażi li waqqfu l-kortikosterojdi b'bidu minn ġimgħa 6 u kienu f'remissjoni klinika f'ġimgħa 52.
English: Low levels (< 300 mcg/L) of vedolizumab were detected on post-partum day 28 in the milk of 3 of 11 cynomolgus monkeys treated 100 mg/kg of vedolizumab dosed every 2 weeks and not in any animals that received 10 mg/kg.
Maltese: 3 minn 11-il xadina cynomolgus ikkurati b'100 mg/kg ta' vedolizumab mogħti kull ġimagħtejn iżda fl-ebda annimal li rċieva 10 mg/kg.
English: Anal Abscess, Anal fissure, Nausea, Dyspepsia, Constipation, Abdominal distension, Flatulence, Haemorrhoids
Maltese: Spażmi fil-muskoli, Uġigħ fid-dahar, Dgħufija fil-muskoli, Għeja, Uġigħ fl-estremità
English: 1 Up to 30 minutes are allowed for reconstitution
Maltese: 1 Għandek sa 30 minuta għar-rikostituzzjoni
English: In these patients, clinical remission was achieved in 46% of patients by 28 weeks and 41% of patients by 52 weeks.
Maltese: F'dawn il-pazjenti, remissjoni klinika inkisbet f'46% tal-pazjenti sa ġimgħa 28 u f'41% tal-pazjenti sa ġimgħa 52.
English: 2630 Taastrup
Maltese: 12-il siegħa2
English: Exploratory analysis show clinically meaningful improvements were observed for vedolizumab groups, and the improvements were significantly greater as compared with the placebo group at week 6 and week 52 on EQ-5D and EQ-5D VAS scores, all subscales of IBDQ (bowel symptoms, systemic function, emotional function and social function), and all subscales of SF-36 including the Physical Component Summary (PCS) and Mental Component Summary (MCS).
Maltese: funzjoni emozzjonali u funzjoni soċjali), u s-sottoskali kollha ta' SF-36 inkluż is-Sommarju tal-Komponent Fiżiku (PCS - Physical Component Summary) u s-Sommarju tal-Komponent Mentali (MCS - Mental Component Summary).
English: If you have previously taken natalizumab (a medicine used to treat multiple sclerosis) or rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis), tell your doctor, who will decide if you can be given Entyvio.
Maltese: Jekk qabel ħadt natalizumab (mediċina użata biex tikkura sklerożi multipla) jew rituximab (mediċina użata biex tikkura ċerti tipi ta' kanċer u l-artrite rewmatika), għid lit-tabib tiegħek, li se jiddeċiedi jekk tistax tingħata Entyvio.
English: The effect of vedolizumab on infants is unknown.
Maltese: L-effetti ta' Entyvio f'nisa tqal mhumiex magħrufa.
English: Takeda GmbH, Podružnica Slovenija Tel.: +386 (0) 59 082 480
Maltese: Takeda Polska Sp. z o.o. Tel.: +48 22 608 13 00
English: If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of Entyvio must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines) (see section 4.3).
Maltese: Jekk isseħħ IRR severa, reazzjoni anafilattika, jew reazzjoni severa oħra, l-għoti ta' Entyvio għandu jitwaqqaf immedjatament u għandha tinbeda kura xierqa (eż., epinephrine u antihistamines) (ara sezzjoni 4.3).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with vedolizumab in one or more subsets of the paediatric population in ulcerative colitis and Crohn's disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'vedolizumab f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika f'kolite ulċerattiva u l-marda ta' Crohn (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • heart burn
Maltese: • sirdat jew tertir
English: If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution.
Maltese: Jekk ma jkunx inħall għal kollox wara 20 minuta, ħalli 10 minuta oħra biex jinħall.
English: The majority of IRRs were mild or moderate in intensity and < 1% resulted in discontinuation of study treatment.
Maltese: Il-maġġoranza ta' IRRs kienu ħfief jew moderati fl-intensità u < 1% wasslu għal waqfien tal-kura tal-istudju.
English: Use aseptic technique when preparing Entyvio solution for intravenous infusion.
Maltese: Uża teknika asettika meta tipprepara Entyvio soluzzjoni għall-infużjoni fil-vini.
English: Clinical response Clinical remission§ Mucosal healing¶
Maltese: Fejqan tal-mukuża Remissjoni klinika li ddum#
English: After reconstitution each mL contains 60 mg of vedolizumab.
Maltese: Wara r-rikostituzzjoni, kull mL fih 60 mg ta' vedolizumab.
English: Fre que ncy
Maltese: Ġimagħtejn wara
English: Efficacy Results for GEMINI II and III Studies at week 6 and week 10
Maltese: Riżultati tal-effikaċja għall-Istudji GEMINI II u III f'ġimgħa 6 u ġimgħa 10
English: A 24 hour period may include up to 8 hours at 2°C-8°C for reconstituted solution in the vial and up to 12 hours at 20°C-25°C for diluted solution in the infusion bag but the infusion bag must be stored in the refrigerator (2°C-8°C) for the rest of the 24 hour period.
Maltese: 24 siegħa jista' jinkludi sa 8 sigħat f'temperatura ta' 2 °C-8 °C għal soluzzjoni rikostitwita f'kunjett u sa 12-il siegħa f'temperatura ta' 20 °C-25
English: By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut.
Maltese: Billi jeħel mal-integrin α4β7 preżenti fuq limfoċiti li jfittxu l-musrana, vedolizumab jeżerċita effett immunosoppressiv speċifiku tal-musrana.
English: Infusion site reaction (including: Infusion site pain and Infusion site irritation), Infusion related reaction, Chills, Feeling cold
Maltese: Irritazzjoni fit-sit tal-infużjoni), Reazzjoni relatata mal-infużjoni,