FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the PRAC noted the available data from studies in surgical and trauma patients and considered that although these studies were limited in size and duration of follow-up they did provide some reassurance that the risks of mortality and renal injury in surgical and trauma patients may be lower than those in the critically ill and sepsis patients.
Maltese: Għalhekk, il-PRAC innota d-dejta disponibbli minn studji f'pazjenti kirurġiċi u bi trawma u kkunsidra li minkejja dawn l-istudji kienu limitati fid-daqs u d-dewmien tas-segwitu, ipprovdew xi riassigurazzjoni li r-riskji ta' mortalità u ħsara renali f'pazjenti kirurġiċi u bi trawma jistgħu jkunu aktar baxxi minn dawk f'pazjenti morda b'mod kritiku.
English: The active ingredient in Halimatoz, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Halimatoz, adalimumab, hija antikorp monoklonali.
English: Halimatoz 40 mg solution for injection in pre-filled syringe with needle guard EU/1/18/1288/001
Maltese: Halimatoz 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bi protezzjoni tal-labra EU/1/18/1288/001
English: Each syringe contains 40 mg/0.8 ml of Halimatoz.
Maltese: Kull pinna fiha 40 mg/0.8 ml ta' Halimatoz.
English: Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab ***,**,* statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
Maltese: Proteina Ċ-reattiva b'sensittività għolja (mg/L) g n=73 plaċebo u n=70 adalimumab h Konsorzju tal-Kanada għar-riċerka ta' Spondyloarthritis i n= 84 plaċebo u adalimumab j n= 82 plaċebo u n=85 adalimumab ***, **, * statistikament sinifikanti meta p < 0.001, < 0.01, u < 0.05, rispettivament, għal paraguni kollha bejn adalimumab u l-plaċebo.
English: Halimatoz is a biosimilar medicinal product.
Maltese: Halimatoz huwa prodott mediċinali bijoloġiku simili.
English: Halimatoz 40 mg injection adalimumab
Maltese: Halimatoz 40 mg injezzjoni adalimumab
English: Halimatoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Maltese: Halimatoz huwa indikat fil-kura ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'pazjenti adulti u adolexxenti minn 12-il sena b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjoni 5.1 u 5.2).
English: • Halimatoz pre-filled SensoReady pen/s (see Figure A).
Maltese: • Halimatoz pinna/pinen mimlija għal-lest SensoReady (ara Figura A).
English: Table 17 Ps study I (REVEAL) - efficacy results at 16 weeks placebo N = 398 n (%)
Maltese: Tabella 17 studju Ps I (REVEAL) - riżultati tal-effikaċja f'16 -il ġimgħa plaċebo
English: Halimatoz is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Maltese: Halimatoz huwa intenzjonat għall-kura tal-marda Crohn (Crohn's disease) fl-adulti u fi tfal li għandhom bejn 6 sa 17-il sena.
English: Thirty-three (18 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79 %) patients with NSAIDs at baseline.
Maltese: Tlieta u tletin (18%) pazjent kienu kkurati fl-istess ħin b'mediċini anti-rewmatiċi li jimmodifikaw ilmarda, u 146 (79%) pazjent b'NSAIDs fil-linja bażi.
English: Halimatoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Halimatoz huwa indikat għall-kura ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li kellhom rispons inadegwat meta ngħataw kura konvenzjonali li tinkludi kortikosterojdi u 6- mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of
Maltese: Matul il-fażijiet IKkontrollati ta' provi pivitali ta' adalimumab fl-adulti li damu sejrin mill-inqas 12 -il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorjasi, hidradenitis suppurativa, mill- marda Crohn (Crohn's disease), kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (95% intervall ta' konfidenza)
English: EU/1/18/1288/004 1 pre-filled pen EU/1/18/1288/005 2 pre-filled pens
Maltese: EU/1/18/1288/004 pinna 1 mimlija għal-lest EU/1/18/1288/005 2 pinen mimlijin għal-lest
English: EU/1/18/1288/001 1 pre-filled syringe EU/1/18/1288/002 2 pre-filled syringes
Maltese: EU/1/18/1288/001 siringa 1 mimlija għal-lest EU/1/18/1288/002 2 siringi mimlijin għal-lest
English: • Halimatoz pre-filled syringe/s (see Figure A).
Maltese: • Halimatoz siringa/i mimlija għal-lest (ara Figura A).
English: • ankylosing spondylitis,
Maltese: • artrite relatata mal-entesite, • ankylosing spondylitis,
English: EU/1/18/1288/003 6 pre-filled syringes (3 packs of 2)
Maltese: EU/1/18/1288/003 6 siringi mimlijin għal-lest (3 pakketti ta' 2)
English: Table 10 radiographic mean changes at week 52 in RA study V
Maltese: Tabella 10 Tibdil medju radjografiku f'ġimgħa 52 fi studju RA V
English: Halimatoz is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: Halimatoz jintuża biex jikkura hidradenitis suppurativa fl-adulti u fl-adolexxenti minn 12-il sena.
English: Halimatoz is used to treat ulcerative colitis in adults.
Maltese: Halimatoz huwa intenzjonat għall-kura ta' kolite ulċerattiva fl-adulti.
English: EU/1/18/1288/006 6 pre-filled pens (3 packs of 2)
Maltese: EU/1/18/1288/006 6 pinen mimlijin għal-lest (3 pakketti ta' 2)
English: How to store Halimatoz
Maltese: Tużax Halimatoz
English: In study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Studju nr-axSpA I Fi Studju nr-axSpA I, adalimumab 40 mg ġimgħa iva u oħra ġie evalwat f'185 pazjent fi studju double blind ikkontrollat bil-plaċebo ta' 12-il ġimgħa f'pazjenti b'nr axSpA attiv (punteġġ medju ta' linja bażi ta' attività ta' mard [Bath Ankylosing Spondylitis Disease Indiċi ta' Attività (BASDAI)] kien 6.4 għal pazjenti ttrattati b'adalimumab u 6.5 għal dawk fuq il-plaċebo) li kellhom rispons inadegwat jew intolleranza għal ≥ 1 NSAIDs, jew kontraindikazzjoni għal NSAIDs.
English: • inject Halimatoz 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Maltese: • tinjetta Halimatoz 15-30 minuta wara li tneħħih mill-friġġ għal injezzjoni aktar komda.
English: Vertigo and visual impairment may occur following administration of Halimatoz (see section 4.8).
Maltese: Jista' jkun hemm vertigo u indeboliment fil-vista wara li tingħata Halimatoz (ara sezzjoni 4.8).
English: Halimatoz dose for paediatric patients with Crohn's disease
Maltese: Doża ta' Halimatoz għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease)
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Maltese: Pazjenti li kisbu remissjoni sostnuta għal mill-inqas 12-il ġimgħa (N = 305) (ASDAS <1.3 fil-Ġimgħa 16, 20, 24 u 28) matul il-perjodu open-label kienu mbagħad ‘randomised' biex jirċievu jew kura kontinwa b'adalimumab 40 mg eow (N=152) jew plaċebo (N=153) għal perjodu ta' 40 ġimgħa addizzjonali f'perjodu double-blind ikkontrollat bi plaċebo (tul totali ta' studju ta' 68 ġimgħa).
English: Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Halimatoz.
Maltese: Il-kartuniet tal-pakkett multiplu fihom 6 (3 pakketti ta' 2) siringi mimlijin għal-lest ta' Halimatoz.
English: The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Maltese: Il-perijodu double-blind kien segwit minn perijodu open-label fejn il-pazjenti rċivew 40 mg Halimatoz taħt il-ġilda ġimgħa iva u ġimgħa le sa 144 ġimgħa addizzjonali.
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte / macrophages, and neutrophils.
Maltese: Immunosoppressjoni Fi studju ta' 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b'adalimumab, ma kien hemm l-ebda evidenza ta' tnaqqis ta' sensitività eċċessiva mdewma, tnaqqis tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelloli effettivi T-, B-, NK-, monoċistiċi / makrofaġi, u newtrofili.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Halimatoz cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti kkurati b'Halimatoz (ara sezzjoni 4.8).
English: Each pen contains 40 mg/0.8 ml of
Maltese: Kull siringa fiha 40 mg/0.8 ml ta'
English: Other medicines and Halimatoz
Maltese: Mediċini oħra u Halimatoz
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'Halimatoz kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 29).
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u s sintomi ta' nr-axSpA attiv f'pazjenti kkurati bi Halimatoz meta mqabbla mal-plaċebo (Tabella 14).
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Halimatoz.
Maltese: Jista' jkun hemm sensazzjoni li l-kamra qed iddur bik (vertigo) u disturbi fil-vista wara li tingħata Halimatoz.
English: Halimatoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Maltese: Halimatoz huwa intenzjonat għall-kura tal-artrite attiva idjopatika poliartikulari taż-żgħażagħ fit-tfal ta' bejn 2 u 17-il sena u artrite relatata mal-entestie fir-tfal u adolexxenti ta' bejn 6 u 17-il sena.
English: Halimatoz dose for patients with polyarticular juvenile idiopathic arthritis
Maltese: Tfal, adolexxenti u adulti bl-artrite idjopatika poliartikulari taż-żgħażagħ
English: Usually, Halimatoz is used with methotrexate.
Maltese: Konsegwentament, Halimatoz jista' jintuża matul it-treddigħ.
English: Halimatoz is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Halimatoz huwa kontroaindikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: Halimatoz is used to treat psoriatic arthritis in adults.
Maltese: Halimatoz jintuża biex jikkura artrite rewmatika fl-adulti.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Halimatoz.
Maltese: Il-kartuni tal-pakkett multiplu fihom 6 (3 pakketti ta' 2) pinen mimlijin għal-lest ta' Halimatoz.
English: Halimatoz contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Maltese: Halimatoz fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq is-sistema immuni (tad-difiża) tal-ġisem.
English: 2 pre-filled pens (SensoReady) Component of a multipack, cannot be sold separately.
Maltese: 2 pinen mimlijin għal-lest (SensoReady) Il-komponent tal-pakkett multiplu ma jistax jinbigħ separatament.
English: Halimatoz 40 mg solution for injection in single-use pre-filled SensoReady pen Halimatoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Maltese: Halimatoz 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest SensoReady Halimatoz jiġi fornut f'siringa mimlija għal-lest li tintuża darba biss f'pinna forma ta' trijanglu b'tieqa u tikketta trasparenti (SensoReady).
English: The recommended Halimatoz induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Maltese: Id-doża inizjali ta' Halimatoz rrakkomandata għal pazjenti adulti b'kolite ulċerattiva minn moderata sa severa, hija ta' 160 mg mogħtija f'Ġimgħa 0 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata jew bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata għal jumejn wara xulxin) u 80 mg f'Ġimgħa 2 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Halimatoz is 40 mg every other week.
Maltese: Tfal, adolexxenti u adulti bl-artrite idjopatika poliartikulari taż-żgħażagħ Tfal, adolexxenti u adulti minn sentejn 'il fuq li jiżnu 30 kg jew aktar Id-doża ta' Halimatoz rrakkomandata hija 40mg ġimgħa iva u ġimgħa le.
English: Halimatoz 40 mg solution for injection in a single-use pre-filled syringe Halimatoz is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Halimatoz 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Halimatoz jiġi fornut f'siringa tal-ħġieġ tat-tip I ċar li tintuża darba biss b'tapp tal-gomma u labra tal istainless steel bil-kappa awtomatika bi flanġ għas-suba', protezzjoni tal-labra tal-gomma u planġer tal-plastik, li fiha 0.8 ml ta' soluzzjoni.
English: • that Halimatoz treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Maltese: o infezzjonijiet, inkluż tuberkulosi o kanċer o problemi fis-sistema nervuża o tilqim
English: • For a more comfortable injection, take your pen out of the refrigerator 15 to 30 minutes before injecting Halimatoz to allow it to reach room temperature.
Maltese: • Għal injezzjoni aktar komda, oħroġ il-pinna mill-friġġ 15 sa 30 minuta qabel tinjetta Halimatoz sabiex tħalliha tilħaq temperatura normali.
English: Halimatoz is used to treat rheumatoid arthritis in adults.
Maltese: Halimatoz jintuża biex jittratta artrite rewmatika fl-adulti.
English: No other disease-modifying anti-rheumatic drugs were allowed.
Maltese: jew li fihom it-terapija konvenzjonali mhix adattata.
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg / ml during the induction period.
Maltese: Doża kbira ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg Halimatoz f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-seru f'adalimumab ta' bejn wieħed u ieħor 12 µg / ml matul il-perijodu tal-bidu.
English: Halimatoz dose for paediatric patients with plaque psoriasis Patient weight
Maltese: Tabella 3. Doża ta' Halimatoz għal pazjenti pedjatriċi bil-psorjasi tal-plakka
English: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Maltese: M'hawnx informazzjoni adegwata minn kura ta' pazjenti li jġorru l-HBV permezz ta' terapija antivirali flimkien ma' terapija b'antagonist ta' TNF biex tiġi evitata r-riattivazzjoni tal-talHBV.
English: Halimatoz is intended for the treatment of the following inflammatory diseases:
Maltese: Halimatoz huwa intenzjonat għall-kura ta' mard infjammatorju:
English: Halimatoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: Psorjasi tal-plakka pedjatrika Halimatoz huwa indikat għall-kura ta' psorjasi tal-plakka severa u kronika fit-tfal u adolexxenti minn 4 snin 'ilfuq u li kellhom rispons inadegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
English: • If you are over 65 years you may be more susceptible to infections while taking Halimatoz.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Halimatoz.
English: Halimatoz is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Maltese: Is-sirigna ġol-pinna hija magħmula minn ħġieġ tat-tip I b'labra tal-istainless steel, u protezzjoni tal-labra ta' ġewwa tal-gomma, u tapp tal-gomma li fiha 0.8 ml ta' soluzzjoni.
English: The recommended Halimatoz dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Maltese: Ir-reġimen tad-doża ta' Halimatoz rrakkomandata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'Jum 1 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Deafness, tinnitus
Maltese: Jekk tinsa tuża Halimatoz
English: Keep Halimatoz and all medicines out of the reach of children.
Maltese: għall-ewwel tingħata mediċini oħra.
English: Halimatoz contains sodium
Maltese: Kif jidher Halimatoz u l-kontenut tal-pakkett
English: The recommended Halimatoz induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Maltese: Ir-reġimen tad-dożaġġ irrakkomandat biex tinbeda l-kura b'Halimatoz għal pazjenti adulti li jbatu mill-marda Crohn (Crohn's disease) b'attività moderata sa severa, huwa ta' 80 mg f'ġimgħa 0 segwiti b'40 mg f'ġimgħa 2.
English: Halimatoz is used to treat moderate to severe plaque psoriasis in adults.
Maltese: Halimatoz huwa intenzjonat għall-kura ta' psorjasi tal-plakka moderata sa severa fl-adulti.
English: By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15).
Maltese: Sal-Ġimgħa 68, pazjenti li kienu qed jirċievu trattament kontinwa b'adalimumab urew titjib statistikament sinifikanti akbar tas-sinjali u s-sintomi ta' nr-axSpA meta mqabbla ma' pazjenti allokati għal irtirar ta' trattament matul il-perjodu double-blind tal-istudju (Tabella 15).
English: ASASa partial remission ASDASc inactive disease partial flared a assessment of SpondyloArthritis International Society b baseline is defined as open label baseline when patients have active disease.
Maltese: Flare Parzjalid a Stima tas-Soċjeta Internazzjonali tas-SpondyloArthritis b Il-linja bażi hija definita bħala linja bażi ‘open label' meta l-pazjenti għandhom mard attiv.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Halimatoz.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini antiinfjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il-kura b'Halimatoz.
English: Halimatoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Maltese: Artrite relata mal-entesite Halimatoz huwa indikat għall-kura ta' artrite attiva relatata mal-entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jittollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: Halimatoz in combination with methotrexate, is indicated for:
Maltese: Halimatoz, flimkien ma' methotrexate, huwa indikat għall-:
English: The Halimatoz 40 mg pre-filled syringe should not be used in children or adolescents weighing less than 40 kg with Crohn's disease, since it is not possible to administer doses less than 40 mg.
Maltese: Halimatoz 40 mg siringa mimlija għal-lest m'għandhiex tintuża fi tfal jew adolexxenti li jiżnu inqas minn 40 kg bil-marda Crohn, peress li mhuwiex possibbli li jingħataw dożi inqas minn 40 mg.
English: and CD8
Maltese: u CD8
English: (see also section 5.1.)
Maltese: (ara wkoll sezzjoni 5.1.)
English: TAKEDA ΕΛΛΑΣ Α.Ε.
Maltese: Ελλάδα TAKEDA ΕΛΛΑΣ Α.Ε.
English: The active substance is vedolizumab.
Maltese: Is-sustanza attiva hi vedolizumab.
English: Tel.: +354 535 7000 vistor@vistor.is
Maltese: +354 535 7000 vistor@vistor.is
English: • acne (pimples)
Maltese: • akne (ponot)
English: ¶Mucosal healing: Mayo endoscopic subscore of ≤ 1 point
Maltese: Sottopunteġġ endoskopiku Mayo ta' ≤1 punt
English: Entyvio is contraindicated in patients with active tuberculosis (see section 4.3).
Maltese: Entyvio huwa kontraindikat f'pazjenti b'tuberkulosi attiva (ara sezzjoni 4.3).
English: 24 hours2, 3
Maltese: 24 siegħa2, 3
English: Administer the infusion solution over 30 minutes (see section 4.2).
Maltese: Għati s-soluzzjoni għall-infużjoni fuq 30 minuta (ara sezzjoni 4.2).
English: Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA33
Maltese: Kategorija farmakoterapewtika: immunosoppressanti, immunosoppressanti selettivi, Kodiċi ATC:
English: Administer the infusion solution over 30 minutes.
Maltese: Għati s-soluzzjoni għall-infużjoni fuq 30 minuta.
English: uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Maltese: (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), u rari ħafna (< 1/10,000).
English: 24 hours2,3
Maltese: 24 siegħa2,3
English: Excipients: Sucrose, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80.
Maltese: Eċċipjenti: Sucrose, L-histidine, monohydrochloride L-histidine, L-arginine hydrochloride, polysorbate 80.