FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency recommended that Clopidogrel TAD be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Clopidogrel TAD ikun approvata għall-użu fl-UE.
English: This summary was last updated in 11-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2017.
English: Spinraza contains the active substance nusinersen.
Maltese: Spinraza fih is-sustanza attiva nusinersen.
English: The full EPAR for Spinraza 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 summary of the opinion of the Committee for Orphan Medicinal Products for Spinraza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Spinraza jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spinraza on 30 May 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Spinraza fit-30 ta' Mejju 2017.
English: This is a summary of the European public assessment report (EPAR) for Spinraza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Spinraza.
English: The medicine is available as a solution for injection in 12 mg vials.
Maltese: Il-mediċina tiġi bħala soluzzjoni għall-injezzjoni f'kunjetti ta' 12 mg.
English: Other information about Spinraza
Maltese: Informazzjoni oħra dwar Spinraza
English: Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of the muscles including the lung muscles.
Maltese: Spinraza hija mediċina li tintuża għall-kura ta' atrofija muskolari tas-sinsla (SMA, spinal muscular atrophy) 5q, marda ġenetika li tikkawża dgħufija u ħela tal-muskoli inkluż il-muskoli tal-pulmun.
English: Patients with SMA lack a protein called ‘survival motor neuron' (SMN) protein, which is essential for motor neurons (nerve cells from the spinal cord that control muscle movements) to survive and function normally.
Maltese: Il-pazjenti b'SMA għandhom proteina nieqsa li tissejjaħ proteina ‘survival motor neuron' (SMN) (motonewruni tas-sopravivenza), li hija essenzjali għall-motonewruni (ċelluli tan-nervituri mis-sinsla tad-dahar li jikkontrollaw il-movimenti tal-muskolu) biex jissopravivu u jiffunzjonaw b'mod normali.
English: After 15 months of treatment, 57% of children receiving Spinraza showed improvement in movement compared with 26% of children on placebo.
Maltese: Wara 15-il xahar ta' kura, 57% ta' tfal li rċevew Spinraza wrew titjib fil-moviment meta mqabbla ma' 26% tat-tfal fuq il-plaċebo.
English: Why is Spinraza approved?
Maltese: Għaliex ġie approvat Spinraza?
English: After one year of treatment, 51% of babies receiving Spinraza (37 out of 73) showed progress in developing head control, rolling, sitting, crawling, standing and walking, whereas no similar progress was seen in any of the babies who received placebo.
Maltese: Wara sena ta' kura, 51 % tat-trabi li rċivew Spinraza (37 minn 73) urew progress fl-iżvilupp talkontroll tar-ras, li jirrumblaw, li joqogħdu bilqiegħda, li jimxu fuq idejhom u rkopptejhom, li joqogħdu bilwieqfa u li jimxu, waqt li ma deher l-ebda progress simili fi kwalunkwe waħda mit-trabi li rċevew ilplaċebo.
English: Because the number of patients with SMA is low, the disease is considered ‘rare', and Spinraza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 April 2012.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn SMA huwa baxx, il-marda hija kkunsidrata ‘rari', u Spinraza ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-2 ta' April 2012.
English: One main study, involving 121 babies (of an average age of 7 months) with SMA, showed that Spinraza is effective in improving movement when compared with placebo (sham injection).
Maltese: Studju ewlieni wieħed, li involva 121 tarbija (ta' età medja ta' 7 xhur) b'SMA, wera li Spinraza huwa effettiv biex itejjeb il-moviment meta mqabbel mal-plaċebo (injezzjoni tal-plaċebo).
English: Spinraza is a synthetic anti-sense oligonucleotide (a type of genetic material) that enables the SMN2 gene to produce full length protein, which is able to work normally.
Maltese: Spinraza huwa oligonukleotidu antisens sintetiku (tip ta' materjal ġenetiku) li jippermetti lill-ġene SMN2 jipproduċi proteina ta' tul sħiħ, li tkun tista' taħdem b'mod normali.
English: The SMN protein is made from two genes, SMN1 and SMN2.
Maltese: Ilproteina SMN hija magħmula minn żewġ ġeni, SMN1 u SMN2.
English: The disease is linked to a defect on chromosome 5q and symptoms usually start shortly after birth.
Maltese: Ilmarda hija marbuta ma' difett fuq il-kromożoma 5q u s-sintomi normalment jibdew ftit wara t-twelid.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku nusinersen
English: What are the risks associated with Spinraza?
Maltese: X'inhuma r-riskji assoċjati ma' Spinraza?
English: Although the medicine was not tested in patients with the most severe and the mildest forms of SMA, it is expected to provide similar benefits to these patients.
Maltese: Għalkemm il-mediċina ma ġietx ittestjata f'pazjenti bl-aktar forom severi u ħfief ta' SMA, huwa mistenni li tipprovdi benefiċċji simili lil dawn il-pazjenti.
English: Another study assessed Spinraza's effectiveness in children whose SMA was less severe and diagnosed at a later stage (average age of 3 years).
Maltese: Studju ieħor ivvalutat l-effettività ta' Spinraza fi tfal li l-SMA tagħhom kienet inqas severa u li ġiet dijanjostikata fi stadju aktar tard (età medja ta' 3 snin).
English: For the full list of all side effects and restrictions with Spinraza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati bi Spinraza, ara l-fuljett ta' tagħrif.
English: Spinraza nusinersen
Maltese: Kif jintuża Spinraza?
English: Spinraza has been shown to lead to clinically meaningful improvements in young children with varying degrees of disease severity.
Maltese: Spinraza ntwera li jwassal għal titjib klinikament sinifikanti fi tfal żgħar bi gradi tas-severità tal-marda li jvarjaw.
English: The recommended dose is 12 mg (one vial), given as soon as possible after the patient has been diagnosed with SMA.
Maltese: Id-doża rakkomandata hija ta' 12 mg (kunjett wieħed), li jingħata malajr kemm jista' jkun wara li lpazjent ikun ġie dijanjostikat b'SMA.
English: The first dose should be followed by 3 more doses after 2, 4, and 9 weeks and then one dose every 4 months thereafter.
Maltese: L-ewwel doża għandha tiġi segwita minn 3 dożi oħra wara ġimagħtejn, 4 u 9 ġimgħat, imbagħad doża waħda kull 4 xhur wara dan.
English: The Agency therefore decided that Spinraza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għalhekk, l-Aġenzija ddeċidiet li l-benefiċċji ta' Spinraza huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: It is not intended to provide practical advice on how to use Spinraza.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Spinraza.
English: The most common side effects with Spinraza (which may affect more than 1 in 10 people) are headache, back pain and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni bi Spinraza (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma uġigħ ta' ras, uġigħ ta' dar u rimettar.
English: In babies some side effects could not be assessed, as they could not communicate them.
Maltese: Fit-trabi xi wħud mill-effetti sekondarji ma setgħux jiġu vvalutati, peress li huma ma setgħux jikkomunikawhom.
English: Pack size
Maltese: Numru tal-MA
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Maltese: Immunosuppressanti, Inibituri ta' Tumur Nekrożi Fattur alfa (TNF-α), Kodiċi ATC: L04AB04
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Maltese: Il-konċentrazzjoni apparenti ta' adalimumab fil-plażma li tipproduċi nofs il-probabbiltà massima ta' rispons PedAc 50 (EC50) kienet ta' 3 μg / ml (95% CI: 1 6 μg / ml).
English: The active ingredient in Hyrimoz, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Hyrimoz, adalimumab, hija antikorp monoklonali.
English: Hyrimoz 40 mg solution for injection in pre-filled syringe with needle guard EU/1/18/1286/001
Maltese: Hyrimoz 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bi protezzjoni tal-labra EU/1/18/1286/001
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Maltese: Nota: P# = Plaċebo (Numru ta' Avvenimenti/Numru fir-Riskju); A#
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: g n=73 plaċebo u n=70 adalimumab h Konsorzju tal-Kanada għar-riċerka ta' Spondyloarthritis i n= 84 plaċebo u Hyrimoz 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: Hyrimoz is a biosimilar medicinal product.
Maltese: Hyrimoz huwa prodott mediċinali bijoloġiku simili.
English: • Hyrimoz pre-filled SensoReady pen/s (see Figure A).
Maltese: • Hyrimoz pinna/pinen mimlija għal-lest SensoReady (ara Figura A).
English: Hyrimoz 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: Hyrimoz 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: Hyrimoz is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Maltese: Hyrimoz huwa intenzjonat għall-kura tal-marda Crohn (Crohn's disease) fl-adulti u fi tfal li għandhom bejn 6 sa 17-il sena.
English: ACTIVATED.
Maltese: methotrexate.
English: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Maltese: Studju PsA II li dam 12-il ġimgħa, ikkura 100 pazjent li kellhom rispons inadegwat għat-terapija DMARD.
English: Hyrimoz 40 mg injection adalimumab
Maltese: Hyrimoz 40 mg injezzjoni adalimumab
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Hyrimoz.
Maltese: Jista' jkun hemm sensazzjoni li l-kamra qed iddur bik (vertigo) u disturbi fil-vista wara li tingħata Hyrimoz.
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Maltese: Il-qlib għall-aħjar fl-istat kliniku (definit bhala CDAI < 150) ġie evalwat f'żewġ studji, studju CD I (CLASSIC I) u studju CD II (GAIN).
English: Usually, Hyrimoz is used with methotrexate.
Maltese: Ġeneralment, Hyrimoz jintuża ma' methotrexate.
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Maltese: double- blind, ikkontrollati bi plaċebo u studju ta' estensjoni open-label f'pazjenti adulti bi hidradenitis suppurativa (HS) moderata sa severa li kienu intolleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill-inqas ta' 3 xhur provi ta' terapija antibijotika sistemika.
English: Hyrimoz 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: Hyrimoz 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: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Maltese: Tnaqqis ta' leżjonijiet infjammatorji u prevenzjoni ta' aggravar ta' axxessi u tal-fistuli li jnixxu ġew evalwati bl-użu ta' Hidradenitis Suppurativa Rispons Kliniku (HiSCR; mill-inqas tnaqqis ta' 50% fl-axxess totali u l-għadd tal-noduli infjammatorji bl-ebda żieda fl-għadd tal-axxess u l-ebda żieda fl għadd relattiv tal-fistula li tkun qed tnixxi mal-Linja Bażi).
English: • Hyrimoz pre-filled syringe/s (see Figure A).
Maltese: • Hyrimoz siringa/i mimlija għal-lest (ara Figura A).
English: How to store Hyrimoz
Maltese: Tużax Hyrimoz
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class (SOC) and frequency in table 6 below: 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); and not known (cannot be estimated from the available data).
Maltese: Il-lista li jmiss ta' reazzjonijiet avversi hija bbażata fuq esperjenza li ġejja minn studji kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq, u hija mniżżla skont is-sistema tal-klassifika tal-organi (SOC) u l-frekwenza f'Tabella 6 hawn taħt: komuni ħafna (≥1/10); komuni (≥1/100 sa < 1/10); mhux komuni
English: Each syringe contains 40 mg/0.8 ml of Hyrimoz.
Maltese: Kull siringa fiha 40 mg/0.8 ml ta' Hyrimoz.
English: EU/1/18/1286/001 1 pre-filled syringe EU/1/18/1286/002 2 pre-filled syringes
Maltese: EU/1/18/1286/001 siringa 1 mimlija għal-lest EU/1/18/1286/002 2 siringi mimlijin għal-lest
English: EU/1/18/1286/003 6 pre-filled syringes (3 packs of 2)
Maltese: EU/1/18/1286/003 6 siringi mimlijin għal-lest (3 pakketti ta' 2)
English: EU/1/18/1286/004 1 pre-filled pen EU/1/18/1286/005 2 pre-filled pens
Maltese: EU/1/18/1286/004 pinna 1 mimlija għal-lest EU/1/18/1286/005 2 pinen mimlijin għal-lest
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Maltese: candidiasis u influwenza), infezzjonijiet intestinali (li jinkludu gastroenterite virali), infezzjonijiet fil-ġilda u fit-tessuti rotob tal-ġilda (li jinkludu infjammazzjoni fit-tessuti tal-ġilda madwar id-difer, ċellulite, impetiġini, faxxite bin-nekrożi u ħruq ta' Sant'Antnin), infezzjonijiet fil-widnejn, infezzjonijiet fil-ħalq (li jinkludu herpes simplex,
English: Hyrimoz is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Maltese: Hyrimoz jintuża biex jikkura hidradenitis suppurativa fl-adulti u fl-adolexxenti minn 12-il sena.
English: Hyrimoz is used to treat ulcerative colitis in adults.
Maltese: Hyrimoz huwa intenzjonat għall-kura ta' kolite ulċerattiva fl-adulti.
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Maltese: < 40 kg • 40 mg f'ġimgħa 0 and 20 mg f'ġimgħa 2
English: b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: c ilvalur-p jiġi mit-tqabbil bejn pari ta' kura b'adalimumab waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney.
English: EU/1/18/1286/006 6 pre-filled pens (3 packs of 2)
Maltese: EU/1/18/1286/006 6 pinen mimlijin għal-lest (3 pakketti ta' 2)
English: Multipack cartons contain 6 (3 packs of 2) pre-filled syringes of Hyrimoz.
Maltese: Il-kartuniet tal-pakkett multiplu fihom 6 (3 pakketti ta' 2) siringi mimlijin għal-lest ta' Hyrimoz.
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Maltese: • vaskulite tal-ġilda (infjammazzjoni tal-vini tal-ġilda); • sindrome Stevens-Johnson (reazzjoni ta' periklu għall-ħajja b'sintomi bħal ta' riħ u raxx bi nfafet);
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumabtreated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16).
Maltese: Ir-rata ta' tqaliet li jintemmu b'għallinqas tarbija tat-twelid ħajja waħda b'difett maġġuri mat-twelid kienet 6/69 (8.7%) fin-nisa kkurati b'adalimumab b' RA u 5/74 (6.8%) fin-nisa mhux ikkurati b'RA (OR mhux aġġustata 1.31, 95% CI 0.38-4.52) u 16/152 (10.
English: Side effects may occur up to 4 months or more after the last Hyrimoz injection.
Maltese: L-effetti sekondarji jistgħu ifeġġu sa 4 xhur jew aktar wara l-aħħar injezzjoni b' Hyrimoz.
English: Do not shake.
Maltese: NE = mhux stmat.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hyrimoz cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti kkurati b'Hyrimoz (ara sezzjoni 4.8).
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test.
Maltese: c il-valur-p jiġi mit-tqabbil bejn pari ta' kura b'Hyrimoz waħdu u methotrexate waħdu bl-użu tat-test U Mann-Whitney.
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 Hyrimoz meta mqabbla mal-plaċebo (Tabella 14).
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'Hyrimoz kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 29).
English: • If you are over 65 years you may be more susceptible to infections while taking Hyrimoz.
Maltese: • Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet aktar faċilment waqt li qed tieħu Hyrimoz.
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Maltese: Studju nr axSpA I evalwa pazjenti b'nr-axSpA attiv.
English: • inject Hyrimoz 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Maltese: • tinjetta Hyrimoz 15-30 minuta wara li tneħħih mill-friġġ għal injezzjoni aktar komda.
English: Hyrimoz is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Hyrimoz huwa kontroaindikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenja, anemija aplastika, avvenimenti li jeffetwaw il-myelin b'mod ċentrali jew periferali u rapporti ta' lupus, kundizzjonijiet relatati ma lupus u s-sindrome ta' Stevens-Johnson.
English: Hyrimoz 40 mg solution for injection in single-use pre-filled SensoReady pen Hyrimoz is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Maltese: Hyrimoz 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest SensoReady Hyrimoz jiġi fornut f'siringa mimlija għal-lest li tintuża darba biss f'pinna forma ta' trijanglu b'tieqa u tikketta trasparenti (SensoReady).
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Maltese: Studju nr-axSpA II 673 pazjent b'attività nr-axSpA (attività medja tal-marda bażika [BASDAI] kienet ta' 7.0) li kellhom rispons inadegwat għal ≥ 2 NSAIDs, jew intolleranza għal jew kontraindikazzjoni għal NSAIDs irreġistrati fil-perjodu open-label ta' Studju nr-axSpA II li matulu rċevew adalimumab 40 mg eow għal 28 ġimgħa.
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Maltese: • disturbi fin-nervituri (bħal infjammazzjoni tan-nerv ottiku tal-għajn u s-sindrome ta'
English: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Maltese: 72 pazjent (63.2 %) kellhom rispons għal ACR 50; u 41 pazjent (36 %) kellhom rispons għal ACR 70.
English: Hyrimoz contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Maltese: Hyrimoz fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq is-sistema immuni (tad-difiża) talġisem.
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 Hyrimoz taħt il-ġilda ġimgħa iva u ġimgħa le sa 144 ġimgħa addizzjonali.
English: The recommended Hyrimoz 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' Hyrimoz 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: Hyrimoz 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: bejn 2 u 17 il-sena u artrite relatata mal-entestie fir-tfal u adolexxenti ta' bejn 6 u 17-il sena.