FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended Humira dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days), followed by 80 mg two weeks later at Day 15.
Maltese: Ir-reġimen tad-doża ta' Humira rrakamondata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'Jum 1 (mogħtija bħala żewġ injezzjonijiet ta' 80 mg f'ġurnata waħda jew bħala injezzjoniji waħda ta' 80 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'Jum 15.
English: The mean steady-state trough concentration at Week 12 through Week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment.
Maltese: Livelli minimali medji fissi tal-konċentrazzjoni f'Ġimgħa 12 sa Ġimgħa 36 kienu bejn wieħed u ieħor 8 sa 10 μg/ml matul trattament b'adalimumab 40 mg kull ġimgħa.
English: One 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Maltese: Siringa waħda ta' 0.8 ml mimlija għal-lest bil-labra mgħottija awtomatika fiha 40 mg adalimumab.
English: • numbness
Maltese: • ansjetà
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
Maltese: • sindromu Stevens-Johnson (is-sintomi bikrija jinkludu sensazzjoni fejn ma tħossokx tajjeb mingħajr ma jkollok l-ebda sintomi ta' mard, deni, uġigħ ta' ras u raxx)
English: The recommended Humira 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' Humira rrakamondata 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: In the open-label extension of RA Study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Maltese: Fil-fażi ta' estensjoni open-label tal-istudju RA III, it-tnaqqis fir-rata ta' progress ta' ħsara strutturali huwa mantenut għal 8 u 10 snin.
English: The syringe is made from type I glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Maltese: Is-siringa hija magħmula minn ħġieġ tip I bi planġer tapp (bromobutyl rubber) u labra bil-kappa (thermoplastic elastomer).
English: Humira 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni fil-kunjetti hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: benign neoplasm
Maltese: Mard awtoimmuni
English: Humira 80 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 80 mg of adalimumab.
Maltese: Humira 80 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 80 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of Humira.
Maltese: Infezzjonijiet fatali u infezzjonijiet li jistgħu jpoġġu l-ħajja fil-periklu, (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), riattivazzjoni tal-HBV u tumuri malinni oħra (li jinkludu lewkimja, limfoma u HSTCL) gew irrapurtati ukoll bl-użu ta' Humira.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Maltese: Fl-istudju UC-II, trattament b'adalimumab irriżulta f'titjib fil-punteġġ tal-Kwestjonarju tal-Marda talInfjammazzjoni tal-Musrana (IBDQ).
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Maltese: ≥ 40 kg • 80 mg f'ġimgħa and 40 mg f' ġimgħa 2
English: Clear Liquid in Syringe
Maltese: Likwidu Ċar fis-Siringa
English: Humira 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.2 ml solution.
Maltese: Humira 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest għal użu pedjatriku hija fornuta bħala soluzzjoni sterili ta' 20 mg adalimumab imdewba f'soluzzjoni ta' 0.2 ml.
English: • stroke
Maltese: • Tirżiħ
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 and frequency in Table 3 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 il-klassi tas-sistema ta' l-organu u lfrekwenza f'Tabella 3 hawn taħt: komuni ħafna ( 1/10); komuni ( 1/100 sa < 1/10); mhux komuni ( 1/1,000 sa< 1/100); rari(  1/10,000 sa < 1/1,000); u mhux magħrufa (li ma jistgħux jiġu kkalkulati mill-informazzjoni eżistenti).
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 14 and 15).
Maltese: Fl-Istudji Psorajisi I u II, punt ta' tmiem primarju kien il-proporzjon ta' pazjenti li kisbu rispons ta' PASI 75 mill-linja bażi f'Ġimgħa 16 (ara t-Tabelli 14 u 15).
English: TNF-antagonists including Humira have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including GuillainBarré syndrome.
Maltese: Antagonisti-TNF, inluż Humira, ġew assoċjati f'okkażjonijiet rari, ma' sintomi kliniċi ġodda jew taħrix ta' sintomi kliniċi u/jew evidenza radjografika ta' mard li jaffetwaw il-myelin tan-nervituri fissistema nervuża ċentrali u jinkludu sklerożi multipla u nevrite ottika u mard li jaffetwaw il-myelin tannervituri fis-sistema periferali, li jinkludu s-sindromu Guillain-Barré.
English: • Plaque psoriasis
Maltese: • Psorjasi tal-plakka
English: Humira/MTX 40 mg every other week
Maltese: Humira/MTX 40 mg ġimgħa iva u ġimgħa le
English: Ltd Τηλ.
Maltese: TISSIKAHX ħafna.
English: Impaired healing
Maltese: Rispons kliniku
English: • cough;
Maltese: • Sogħla;
English: • itching;
Maltese: • kanċer;
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: • 1 pre-filled syringe with automatic needle guard (0.4 ml sterile solution) with 1 alcohol pad in a blister.
Maltese: • Syringa waħda mimlija għal-lest (0.4 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja.
English: At week 16, more patients randomised to Humira 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Maltese: F'ġimgħa 16, aktar pazjenti magħżula b'mod każwali u li ngħataw Humira 0.8 mg/kg kellhom rispons pożittivi tal-effikaċja (eż, PASI 75) milli dawk każwali għal 0.4 mg/kg eow jew MTX.
English: A single Humira pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Maltese: Siringa mimlija għal-lest ta' Humira tista' tinħażen f'temperaturi sa massimu ta' 25 ° C għal perjodu ta' mhux aktar minn 14-il jum.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Maltese: Dawn l-infezzjonijiet jistgħu jkunu serji u jinkludu tuberkulosi, infezzjonijiet ikkawżati minn virus, fungus, parassiti jew batterji jew infezzjonijiet opportunistiċi u sepsis oħra li, f'każi rari, jistgħu ipoġġu l-ħajja fil-periklu.
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at Week 0 and 80 mg at Week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Maltese: Is-suġġetti kollha ngħataw kura tal-bidu open-label b'doża fuq bażi tal-linja bażi tal-piż tal-ġisem tagħhom: 160 mg f'Ġimgħa 0 u 80 mg f'Ġimgħa 2 għal suġġetti ≥ 40 kg, u 80 mg u 40 mg, rispettivament, għal suġġetti < 40 kg.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 12).
Maltese: Fi Studju RA V, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (ara Tabella 12).
English: Table 21 Maintenance of Clinical Remission and Response (Percent of Patients) Placebo
Maltese: Tabella 21 Iż-Żamma tat-Titjib Kliniku u tar-Rispons (Persentaġġ ta' Pazjenti) Plaċebo
English: • 3 pre-filled pens (0.8 ml sterile solution), with 4 alcohol pads in a blister.
Maltese: • 4 pinnen mimlijin għal-lest (0.4 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: 4 pre-filled pens 4 alcohol pads
Maltese: 4 pinen mimlijin għal-lest 4 kuxxinetti bl-alkoħol
English: First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later.
Maltese: Doża inizjali ta' 160 mg (bħala 4 injezzjonijiet ta' 40 mg f'ġurnata waħda jew 2 injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti b'doża ta' 80 mg (bħala 2 injezzjonijiet ta' 40 mg flistess ġurnata ) ġimagħtejn wara.
English: The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Maltese: Il-pazjenti fil-HS-I u HS-II kellhom marda Hurley Istadju II jew III ma' mill-inqas 3 axxessi jew noduli infjammatorji.
English: • muscle spasms;
Maltese: • uġigħ muskolu-skeltrali
English: By Week 68, patients receiving continuous Humira 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'Humira wrew 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: Humira 80 mg solution for injection in pre-filled syringe with automatic needle guard Each 0.8 ml single dose pre-filled syringe contains 80 mg of adalimumab.
Maltese: Humira 80 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 80 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Pancreatitis, dysphagia, face oedema
Maltese: Uġigħ fis-sider, edima, deni
English: How to store Humira
Maltese: Biex Tinjetta Humira
English: Adult plaque psoriasis
Maltese: Psorjasi tal-plakka fl-Adulti
English: Table 23 Maintenance of Clinical Remission and Response (Percent of Patients) Placebo
Maltese: Tabella 23 Iż-Żamma tat-Titjib Kliniku u tar-Rispons (Persentaġġ ta' Pazjenti) Plaċebo
English: blood lactate dehydrogenase increased
Maltese: Uveite mhux infettiva fl-adulti u tfal
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 days * p < 0.001 for Humira versus placebo pairwise comparisons of proportions ** p < 0.02 for Humira versus placebo pairwise comparisons of proportions Of those receiving corticosteroids at baseline
Maltese: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal Humira kontra lplaċebo ** p < 0.02 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal Humira kontra lplaċebo a
English: Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: Humira huwa ndikat għall-kura tal-marda Crohn (Crohn's diease) attiva minn moderata sa severa fittfal (minn 6 snin il-fuq) li ma kellhomx rispons kif mistenni għall-kura konvenzjonali inkluż terapija ta' nutrizzjoni primarja u kortikosterojde u/jew immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: b p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: b valur p għall-paraguni magħmula bejn kull par ta' monoterapija b'Humira u terapija kombinata ta' Humira/methotrexate permezz tat-test Mann-Whitney U.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira 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'Humira kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 28).
English: • SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose.
Maltese: • Iġbed il-planġer BIL-MOD ‘il barra sa 0.1 ml aktar mid-doża preskritta.
English: Humira 80 mg solution for injection in pre-filled syringe with automatic needle guard is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml solution.
Maltese: Humira 80 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bil-labra mgħottija awtomatika hija fornuta bħala soluzzjoni sterili ta' 80 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Concurrent administration of biologic DMARDS or TNF-antagonists
Maltese: L-għoti flimkien ta' DMARDS bijoloġiċi jew ta' antagonisti TNF
English: • At least 3 cm from your last injection site
Maltese: • Mill-inqas 3 ċm mill-aħħar post tal-injezzjoni tiegħek
English: • 1 pre-filled syringe (0.4 ml sterile solution) with 1 alcohol pad in a blister.
Maltese: • 4 syringi mimlijin għal-lest (0.4 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: Humira in combination with methotrexate, is indicated for:
Maltese: Humira, flimkien ma' methotrexate, huwa indikat għall-:
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Maltese: L-aktar reazzjonijiet avversi li gew irrapurtati b'mod komuni huma infezzjonijiet (bħal nasofarinġite, infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja u sinożite), reazzjonijiet fil-post ta' l-injezzjoni (eritema, ħakk, emorraġija, uġigħ jew nefħa), uġigħ ta' ras u uġigħ muskolu-skeletrali.
English: aspergillosis and listeriosis).
Maltese: - Żomm dan il-fuljett.
English: • 1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister.
Maltese: • 2 siringi mimlijin għal-lest (0.8 ml soluzzjoni sterili), b'kuxxinett wieħed bl-alkoħol f'folja kull wieħed.
English: One 0.4 ml pre-filled pen contains 40 mg adalimumab.
Maltese: Pinna waħda ta' 0.4 ml mimlija għal-lest fiha 40 mg adalimumab.
English: b p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: c valur p għall-paraguni magħmula bejn kull par ta' monoterapija b'Humira u terapija kombinata ta' Humira/methotrexate permezz tat-test Mann-Whitney U.
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Maltese: Matul is-19-il suġġett kollha, li minnhom 11 mill-grupp ta' linja bażi ta' grupp ta' età 4 sa 12 u 8 ta' linja bażi ta' grupp ta' età 13 sa 17-il sena ġew ittrattati 6 snin jew aktar.
English: Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Maltese: L-għoti flimkien ta' adalimumab ma' DMARDS bijoloġiċi oħra (e.ż. anakinra u abatacept) jew antagonisti ta' TNF oħra, mhux rakkomandat fuq bażi ta' żieda possibli fir-riskju ta' infezzjonijiet, inkluż infezzjonijiet serji u interazzjonijiet oħra ta' potenzjal farmakoloġiku.
English: Humira 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Maltese: Tfal u adolexxenti minn 4 sa 17-il sena li jiżnu 30kg jew aktar
English: In the Phase 3 trial of Humira in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Maltese: Fil-prova ta' Fażi 3 ta' Humira fit-tfal bil-marda Crohn (Crohn's disease) li evalwat l-effikaċja u ssigurtà f'żewġ reġimi ta' dożaġġ ta' manteniment irranġati skont il-piż tal-ġisem wara terapija tal-bidu li wkoll kienet irranġata skont il-piż tal-ġisem sa 52 ġimgħa ta' trattament, kien hemm żidiet fl-ALT ta' ≥ 3 x ULN f'2.6% (5/192) tal-pazjenti li minnhom 4 kienu qed jirċievu immunosuppressanti konkomitanti fil-linja bażi.
English: Table 11 Radiographic Mean Changes Over 12 Months in RA Study III
Maltese: Tabella 11 Tibdil Medju Radjografiku fuq perjodu ta' 12 -il xahar fi Studju RA III
English: • bruising
Maltese: • puplesija
English: Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
Maltese: Tfal u adoloxxenti minn età ta' sentejn li jiżnu mill-inqas 30 kg
English: 3 pre-filled pens 4 alcohol pads
Maltese: 3 pinen mimlijin għal-lest 4 kuxxinetti bl-alkoħol
English: Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard Each 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.4 ml.
English: • Adolescent hidradenitis suppurativa
Maltese: • Hidradenitis suppurativa fl-adolexxenti
English: • Keeping the syringe up, insert the syringe tip into the yellow syringe connector and twist the syringe as indicated by the arrow in the picture until firm.
Maltese: • Tippruvax tinjetta lilek innifsek sakemm inti żgur li fhimt kif tipprepara u tagħti l-injezzjoni.
English: a p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: . valur p għall-paraguni magħmula bejn kull par ta' monoterapija b'methotrexate u terapija kombinata ta' Humira/methotrexate permezz tat-test Mann-Whitney U.
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Maltese: Figura 1: Kurvi ta' Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment tatTrattament fl-Istudju Pedjatriku tal-Uveite
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Maltese: Tfal u adoloxxenti minn 6 sa 17-il sena li jiżnu inqas minn 40 kg
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Maltese: L-espożizzjoni ta' Adalimumab f'pazjenti pedjatriċi b'uveite kienet imbassra bl-użu ta' mudellar farmakokinetiku tal-popolazzjoni u simulazzjoni bbażata fuq farmakokinetika ta' indikazzjoni minn pazjenti pedjatriċi oħra (psorijasi pedjatrika, artrite idjopatika minorenni, marda ta' Crohn pedjatrika u artrite relatata mal-entesite).
English: • 1 pre-filled syringe with automatic needle guard (0.8 ml sterile solution) with 1 alcohol pad in a blister.
Maltese: • Pinna waħda mimlija għal-lest (0.8 ml soluzzjoni sterili), b'żewġ kuxxinetti bl-alkoħol f'folja.
English: • facial oedema (swelling of the face)
Maltese: • edema fil-wiċċ (nefħa tal-wiċċ)
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Maltese: • Żomm il-pakkett tas-siringa u BIL-MOD iġbed l-istikka bajda tal-planġer ‘il barra sa 0.1 ml aktar mid-doża preskritta (Per eżempju, jekk id-doża preskritta hiija 0.5ml, iġbed l-istikka bajda tal-planġer sa 0.6 ml).
English: • sensation disorders such as tingling, prickling or numbness
Maltese: • disturbi ta' sensazzjoni bħal tnemnim, tingiż jew tirżiħ
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Maltese: Ipponta il-vleġġa l-bajda lejn il-post tal-injezzjoni (koxxa jew fl-addome).
English: Press the plum activator button and count slowly for 15 seconds.
Maltese: Agħfas l-buttuna tal-attivatur kulur l-għanbaqra u għodd bilmod għal 15-il sekonda.
English: At Week 16, a statistically significantly greater proportion of patients who received Humira achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
Maltese: F'Ġimgħa 16, kien hemm proporzjon akbar statistikament sinifikanti ta' pazjenti li rċevew Humira leħqu PGA ta' ‘ċar' jew ‘kważi ċar' għal psorijasi fl-idejn u/jew fis-saqajn meta mqabbel mal-pazjenti li rċevew il-plaċebo (30.6% kontra 4.3%, rispettivament [P=0.014]).